HealthyPhase 1NCT02036775

Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers

A Phase 1 study testing Lasolvan tablet, Lasolvan effervescent tablet and Lasolvan prolonged-release hard capsule in people with Healthy, run by Boehringer Ingelheim at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To characterise pharmacokinetics and assess the relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lasolvan tablet, Lasolvan effervescent tablet and Lasolvan prolonged-release hard capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteRussia
Study dates: Mar 2014to May 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Given written informed consent for participation in the study.
Male and female subjects aged 18-45, inclusive.
Body mass index by Quetelet 18.50 - 24.99 kg/m2, inclusive.
Judged by the investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, and renal systems), vital signs assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities outside normal ranges for any clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the investigator and judged to be not clinically significant for the study participation.
Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If female is postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, they should be withdrawn at least 2 months before the study.
Male subjects who agree on using effective contraception during the study (barrier contraceptive methods).

Who cannot join

Known hypersensitivity to ambroxol hydrochloride, or other constituents of the test and reference products.
Known rare hereditary conditions (Stevens-Johnson syndrome, toxic epidermal necrolysis, galactose intolerance, Lapp-lactase deficiency, glucose-galactose malabsorption).
Pregnancy or breastfeeding.
Chronic hepatic, renal, cardiovascular, respiratory, gastrointestinal, neuroendocrine diseases and blood disorders.
Positive results of blood tests for current infections (HIV, syphilis, hepatitis B or C).
Surgery of gastro-intestinal tract (except of appendectomy) within the past 8 weeks.

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Acute infections occurred within 4 weeks before inclusion into the study.
Regular drug intake within 2 weeks before inclusion into the study.
Intake of systemic drugs known to affect cytochrome P450 system (induce or inhibit) within 4 weeks before inclusion into the study.
Blood donation (greater or equal 450 ml) within 2 months before inclusion into the study.
Alcohol intake greater than or equal to 10 units of alcohol per week (1 unit of alcohol equals one 50 ml single measure of whisky (ABV - alcohol by volume 40%), or 0.5 litre of beer (ABV 5%), or 200 ml glass of red wine (ABV 12%) or history of alcohol abuse, narcomania, or other drug abuse.
A positive urine drug test (cannabis, benzodiazepines, barbiturates, opiates, cocaine, amphetamines) at screening and before the first dosing in each study period.
A positive alcohol test at screening and before the first dosing in each study period
Participation in another phase I clinical study within 3 months before inclusion into the study.
Known lactose intolerance.
Known phenylketonuria

Trial locations and contacts

1 site in 1 country.

Russia1 site

18.510.2 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

About this study

Official title: An Open-label, Randomised, Multiple-dose, Three-period Crossover Study in Healthy Male and Female Volunteers to Characterise Pharmacokinetics and Assess the Relative Bioavailability of Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolonged-release Hard Capsules 75 mg and Lasolvan® Effervescent Tablets 60 mg Compared to Lasolvan® Tablets 30 mg.

Conditions: Healthy
Being tested: Lasolvan tablet, Lasolvan effervescent tablet, Lasolvan prolonged-release hard capsule, Lasolvan prolonged-released capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Lasolvan prolonged-release hard capsuleDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan prolonged-release hard capsuleDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan prolonged-released capsulesDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan tabletDrug
One Lasolvan tablet 30 mg twice daily for 5 days.
Lasolvan prolonged-release hard capsuleDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Lasolvan prolonged-release hard capsuleDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan prolonged-release hard capsuleDrug
One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
Lasolvan effervescent tabletDrug
One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.

Study groups in NCT02036775
Study group	Role	What they receive
Treatment sequence 1	Experimental	Treatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2 Receives: Drug: Lasolvan tablet; Drug: Lasolvan prolonged-released capsules; Drug: Lasolvan effervescent tablet
Treatment sequence 2	Experimental	Treatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product Receives: Drug: Lasolvan tablet; Drug: Lasolvan effervescent tablet; Drug: Lasolvan prolonged-release hard capsule
Treatment sequence 3	Experimental	Reference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1 Receives: Drug: Lasolvan effervescent tablet; Drug: Lasolvan tablet; Drug: Lasolvan prolonged-release hard capsule
Treatment Sequence 4	Experimental	Treatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1 Receives: Drug: Lasolvan tablet; Drug: Lasolvan effervescent tablet; Drug: Lasolvan prolonged-release hard capsule
Treatment sequence 5	Experimental	Reference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2 Receives: Drug: Lasolvan tablet; Drug: Lasolvan prolonged-release hard capsule; Drug: Lasolvan effervescent tablet
Treatment Sequence 6	Experimental	Treatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product Receives: Drug: Lasolvan tablet; Drug: Lasolvan effervescent tablet; Drug: Lasolvan prolonged-release hard capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Maximum Measured Concentration of the Analyte in Plasma at Steady State
Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Secondary outcomes (9)

Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg
Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)
Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval
Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State
Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma
Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Peak-trough Swing
Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100)
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Time Period When Concentration of the Analyte Exceeds Cav ss
Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss))
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss
Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss))
Measured: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014May 2014

First posted15 Jan 2014 (estimated)
Study startMar 2014
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02036775
Sponsor's protocol ID: 18.510
Status last verified: May 2015
First submitted: 13 Jan 2014
Last updated: 13 May 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Ollier C, Sent U, Mesquita M, Michel MC. Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan(R) Retard) Compared with Other Formulations in Healthy Volunteers. Pulm Ther. 2020 Jun;6(1):119-130. doi: 10.1007/s41030-020-00116-7. Epub 2020 May 5.
PubMed 32372294

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Multiple-dose, Three-period Crossover Study in Healthy Male and Female Volunteers to Characterise Pharmacokinetics and Assess the Relative Bioavailability of Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolonged-release Hard Capsules 75 mg and Lasolvan® Effervescent Tablets 60 mg Compared to Lasolvan® Tablets 30 mg.
ClinicalTrials.gov ID: NCT02036775
Acronym / sponsor ID: 18.510
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 15 Jan 2014 (estimated)
Results: Posted 13 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment sequence 1	Experimental	Drug: Lasolvan tablet, Drug: Lasolvan prolonged-released capsules, Drug: Lasolvan effervescent tabletTreatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2
Treatment sequence 2	Experimental	Drug: Lasolvan tablet, Drug: Lasolvan effervescent tablet, Drug: Lasolvan prolonged-release hard capsuleTreatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product
Treatment sequence 3	Experimental	Drug: Lasolvan effervescent tablet, Drug: Lasolvan tablet, Drug: Lasolvan prolonged-release hard capsuleReference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1
Treatment Sequence 4	Experimental	Drug: Lasolvan tablet, Drug: Lasolvan effervescent tablet, Drug: Lasolvan prolonged-release hard capsuleTreatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1
Treatment sequence 5	Experimental	Drug: Lasolvan tablet, Drug: Lasolvan prolonged-release hard capsule, Drug: Lasolvan effervescent tabletReference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2
Treatment Sequence 6	Experimental	Drug: Lasolvan tablet, Drug: Lasolvan effervescent tablet, Drug: Lasolvan prolonged-release hard capsuleTreatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Given written informed consent for participation in the study.
Male and female subjects aged 18-45, inclusive.
Body mass index by Quetelet 18.50 - 24.99 kg/m2, inclusive.
Judged by the investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, and renal systems), vital signs assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities outside normal ranges for any clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the investigator and judged to be not clinically significant for the study participation.
Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If female is postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, they should be withdrawn at least 2 months before the study.

Key exclusion criteria (16 listed)

Known hypersensitivity to ambroxol hydrochloride, or other constituents of the test and reference products.
Known rare hereditary conditions (Stevens-Johnson syndrome, toxic epidermal necrolysis, galactose intolerance, Lapp-lactase deficiency, glucose-galactose malabsorption).
Pregnancy or breastfeeding.
Chronic hepatic, renal, cardiovascular, respiratory, gastrointestinal, neuroendocrine diseases and blood disorders.
Positive results of blood tests for current infections (HIV, syphilis, hepatitis B or C).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment sequence 1
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment sequence 2
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment Sequence 4
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment Sequence 6
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment sequence 3
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment Sequence 4
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment Sequence 6
Lasolvan prolonged-release hard capsuleOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment Sequence 4
Lasolvan prolonged-release hard capsuleOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment Sequence 6
Lasolvan prolonged-released capsulesOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment sequence 1
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment sequence 3
Lasolvan tabletOne Lasolvan tablet 30 mg twice daily for 5 days.	Drug	Treatment sequence 5
Lasolvan prolonged-release hard capsuleOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment sequence 3
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment sequence 2
Lasolvan prolonged-release hard capsuleOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment sequence 5
Lasolvan prolonged-release hard capsuleOne Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days	Drug	Treatment sequence 2
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment sequence 5
Lasolvan effervescent tabletOne-half Lasolvan effervescent tablet 60mg twice daily for 5 days.	Drug	Treatment sequence 1

Primary outcome

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)
Maximum Measured Concentration of the Analyte in Plasma at Steady State
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)

9 secondary outcomes

Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Peak-trough Swing
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Time Period When Concentration of the Analyte Exceeds Cav ss
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg
Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss
Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Results and safety

Results posted to the registry on 13 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg	4	4
Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg	4	4
Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg	4	4
Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg	4	4
Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg	4	4
Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg	4	4

Primary outcome: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State

Time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Lasolvan 75mg n = 23	Lasolvan 60mg n = 23	Lasolvan 30mg n = 23
Value	1182.084 (28.859)	1110.095 (28.292)	1070.909 (32.259)

Lasolvan 75mg vs Lasolvan 30mg: Adjusted Geometric Mean Ratio (%): 110.68 (90% CI 99.84 to 122.69)
Lasolvan 60mg vs Lasolvan 30mg: Adjusted Geometric Mean Ratio (%): 103.39 (90% CI 96.54 to 110.74)
Lasolvan 75mg vs Lasolvan 60mg: Adjusted Geometric Mean Ratio (%): 106.93 (90% CI 100.29 to 114.02)

Population analysed: Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.

Primary outcome: Maximum Measured Concentration of the Analyte in Plasma at Steady State

Measure	Lasolvan 75mg n = 23	Lasolvan 60mg n = 23	Lasolvan 30mg n = 23
Value	73.510 (26.927)	90.755 (34.426)	87.289 (34.426)

Lasolvan 75mg vs Lasolvan 30mg: Adjusted Geometric Mean Ratio (%): 84.72 (90% CI 76.96 to 93.25)
Lasolvan 60mg vs Lasolvan 30mg: Adjusted Geometric Mean Ratio (%): 103.87 (90% CI 95.22 to 113.31)
Lasolvan 75mg vs Lasolvan 60mg: Adjusted Geometric Mean Ratio (%): 80.94 (90% CI 73.92 to 88.62)

Population analysed: PK-BA set

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until the end of the consequent residual effect period (24 hours) for the treatment taken immediately before, 6 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lasolvan 75mg	0 of 24 (0%)	0 of 24 (0%)	Not reported
Lasolvan 60mg	0 of 24 (0%)	0 of 24 (0%)	Not reported
Lasolvan 30mg	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32372294Ollier C, Sent U, Mesquita M, Michel MC. Pharmacokinetics of Ambroxol Sustained Release (Mucosolvan(R) Retard) Compared with Other Formulations in Healthy Volunteers. Pulm Ther. 2020 Jun;6(1):119-130. doi: 10.1007/s41030-020-00116-7. Epub 2020 May 5.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lasolvan tablet, Lasolvan effervescent tablet and Lasolvan prolonged-release hard capsule in people with Healthy, run by Boehringer Ingelheim at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State (time frame: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.