HealthyPhase 1NCT03684265

A Study to Compare the Amount of Meloxicam in the Blood When it is Taken as Capsules or as Tablets

A Phase 1 study testing Meloxicam Capsule (Test) and Meloxicam Tablet (Reference) 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

The primary objective of the study is to investigate the relative bioavailability of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R). The secondary objective of the study is to establish bioequivalence of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R). 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?: Meloxicam Capsule (Test) and Meloxicam Tablet (Reference)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteRussia
Study dates: 5 Oct 2018to 6 Nov 2018
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

Male and female subjects aged 18-45, inclusive.
Body mass index by Quetelet between 18.50 -29.99 kg/m2, inclusive.
The verified diagnosis is "healthy" according to the conclusion investigator according to the information in the anamnesis, the results of the physical examination, the Electrocardiogram (ECG), the results of measurement of vital signs of the body (blood pressure, heart rate, breathing rate and body temperature), and laboratory indicators.
Pre-conducting standard clinical and laboratory and instrumental studies did not reveal the presence of any diseases and abnormalities.
Systolic blood pressure not less than 100 mm Hg. and not higher than 139 mm Hg. diastolic blood pressure not less than 70 mm Hg. and not more than 90 mm Hg. the heart rate is not less than 60 beats per minute and not more than 90 beats per minute, the frequency of respiratory movements is within the range of 12-20 per minute.
Ability to understand and accept the explanation of the study; the written informed consent of the volunteer to participate in the study in accordance with applicable law.
Female subjects of childbearing potential who agree on using double-barrier contraception from a screening visit to 30 days after the last administration of the study drug, inclusive. If a 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, these should be withdrawn at least 2 months before the study.
Male subjects who agree on using effective contraception (barrier contraceptive methods) from a screening visit to 30 days after the last administration of the study drug, inclusive.

Who cannot join

Drug intolerance of any drug.
Allergic history.
Acute infectious diseases or allergic reactions requiring treatment (including drug allergy), less than 4 weeks before the screening.
Surgical interventions on the gastrointestinal tract (with the exception of appendectomy), which can have a significant effect on the absorption or metabolism of study drugs.
Known hypersensitivity to meloxicam or any excipient of the test and reference products.
Known hypersensitivity to other Non-steroid anti-inflammatory drug (NSAIDs): subjects who have developed signs of asthma, nasal polyps, angio-oedema or urticarial following the administration of acetylsalicylic acid or other NSAIDs.

Show all 36Show fewer

Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, or other conditions that make it impossible for the volunteer to participate in the study according to the investigator opinion.
The results of standard laboratory and instrumental methods of examination, obtained during the screening, go beyond normal values.
History of gastro-intestinal ulceration/ perforation or bleeding; history of malignancy within 5 years before the screening.
Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C) at screening.
A positive alcohol test at screening.
A positive urine drug test (cannabis, benzodiazepines, barbiturates, opiates, cocaine, and amphetamines) at screening.
Pregnancy or breastfeeding.
Any diet, for example, vegetarian, for 2 weeks before the first day of screening.
Alcohol intake more than 10 units. alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of wine or 50 ml of alcohol) or anamnestic information about alcoholism, drug addiction, abuse of medicines.
The inability to be without food for at least 12 hours and the inability to take the drug on an empty stomach.
Blood donation (≥ 450 ml) within 3 months before screening.
Depot injections, the installation of intrauterine hormonal therapy systems or implants of any drugs for 6 months before the screening;
For women: use of hormonal contraceptives less than 2 months before the screening.
Regular drug intake within 2 weeks before the screening.
Intake of systemic drugs known to alter liver function (barbiturates, omeprazole, cimetidine) within 4 weeks before the screening.
For women: volunteers with preserved reproductive potential who had unprotected intercourse with an unsterilized male partner for 30 days before the screening
Participation in another clinical trial within 3 months before the screening.
Difficult access to the vein, complicating or making it impossible to install a catheter and frequent blood sampling.
Smoker (≥10 cigarettes or ≥ 3 pipes per day).
Inability to refrain from smoking on study days.
Volunteers who do not want or are unable to give up alcohol and excessive physical exertion from the first day of screening and before the visit of follow-up.
Volunteers who are unwilling or unable to refuse drinks and food containing methylxanthines (coffee, tea, cola, energy drinks, chocolate, etc.) and grapefruit / grapefruit juice, Seville oranges (sour or bitter oranges) and their juices, and dietary supplements and products including St. John's wort (Hypericum perforatum) from the first day of screening and until a follow-up visit.
Volunteers who lead a lifestyle (including night work and extreme physical activities such as sports or weight lifting), which can make it difficult to interpret the laboratory data obtained during the study.
Volunteers who do not intend to comply with the study regime.
Volunteers who are obviously or probably, in the opinion of the investigator, are not able to understand and evaluate the information on this study in the process of signing the ICF, in particular regarding the expected risks and possible discomfort.
The presence of volunteers dehydration due to diarrhea, vomiting or other cause within the last 24 hours before the first day of screening.
The presence of volunteers attacks of seizures, epilepsy and any other neurological disorders in the anamnesis
Recent cerebrovascular bleeding or established systemic bleeding disorders.
Known lactose intolerance.
Reports difficulty for swallowing tablets or capsules.

Trial locations and contacts

1 site in 1 country.

Russia1 site

City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow
Moscow, 109263

Other trials in Russia

About this study

Official title: An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Volunteers to Evaluate the Relative Bioavailability of a New Oral Formulation of Meloxicam, Movalis® Capsules 15 mg, Versus Movalis® Tablets 15 mg, After Administration Under Fasting State.

The primary objective of the study is to investigate the relative bioavailability of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

The secondary objective of the study is to establish bioequivalence of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

Conditions: Healthy
Being tested: Meloxicam Capsule (Test), Meloxicam Tablet (Reference)

What participants receive

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

Meloxicam Capsule (Test)Drug
Also called Movalis
single dose
Meloxicam Tablet (Reference)Drug
Also called Movalis
single dose

Study groups in NCT03684265
Study group	Role	What they receive
Test to Reference	Experimental	Not described Receives: Drug: Meloxicam Capsule (Test); Drug: Meloxicam Tablet (Reference)
Reference to Test	Experimental	Not described Receives: Drug: Meloxicam Capsule (Test); Drug: Meloxicam Tablet (Reference)

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 the Last Quantifiable Data Point (AUC0-t)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).
Standard error is actually Geometric standard error.
Measured: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
Maximum Measured Concentration of the Analyte in Plasma (Cmax)
Maximum measured concentration of the analyte in plasma (Cmax).
Standard error is actually Geometric standard error.
Measured: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose

Secondary outcomes (1)

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Standard error is actually Geometric standard error.
Measured: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose

Timeline

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

5 Oct 20186 Nov 2018

First posted25 Sep 2018
Study start5 Oct 2018
Primary completion30 Oct 2018
Study completion6 Nov 2018

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.
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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03684265
Sponsor's protocol ID: 0107-0277
Status last verified: Nov 2019
First submitted: 24 Sep 2018
Last updated: 22 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Volunteers to Evaluate the Relative Bioavailability of a New Oral Formulation of Meloxicam, Movalis® Capsules 15 mg, Versus Movalis® Tablets 15 mg, After Administration Under Fasting State.
ClinicalTrials.gov ID: NCT03684265
Acronym / sponsor ID: 0107-0277
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 5 Oct 2018 (actual)
Primary completion: 30 Oct 2018 (actual)
Study completion: 6 Nov 2018 (actual)
First posted: 25 Sep 2018 (actual)
Results: Posted 22 Nov 2019

Clinical summary

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

The primary objective of the study is to investigate the relative bioavailability of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

The secondary objective of the study is to establish bioequivalence of Movalis capsules 15 mg (Test, T) versus Movalis tablets 15 mg (Reference, R).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test to Reference	Experimental	Drug: Meloxicam Capsule (Test), Drug: Meloxicam Tablet (Reference)
Reference to Test	Experimental	Drug: Meloxicam Capsule (Test), Drug: Meloxicam Tablet (Reference)

Who may qualify

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

Key inclusion criteria (8 listed)

Male and female subjects aged 18-45, inclusive.
Body mass index by Quetelet between 18.50 -29.99 kg/m2, inclusive.
The verified diagnosis is "healthy" according to the conclusion investigator according to the information in the anamnesis, the results of the physical examination, the Electrocardiogram (ECG), the results of measurement of vital signs of the body (blood pressure, heart rate, breathing rate and body temperature), and laboratory indicators.
Pre-conducting standard clinical and laboratory and instrumental studies did not reveal the presence of any diseases and abnormalities.
Systolic blood pressure not less than 100 mm Hg. and not higher than 139 mm Hg. diastolic blood pressure not less than 70 mm Hg. and not more than 90 mm Hg. the heart rate is not less than 60 beats per minute and not more than 90 beats per minute, the frequency of respiratory movements is within the range of 12-20 per minute.

Key exclusion criteria (36 listed)

Drug intolerance of any drug.
Allergic history.
Acute infectious diseases or allergic reactions requiring treatment (including drug allergy), less than 4 weeks before the screening.
Surgical interventions on the gastrointestinal tract (with the exception of appendectomy), which can have a significant effect on the absorption or metabolism of study drugs.
Known hypersensitivity to meloxicam or any excipient of the test and reference products.

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
Meloxicam Capsule (Test)Also: Movalissingle dose	Drug	Reference to Test, Test to Reference
Meloxicam Tablet (Reference)Also: Movalissingle dose	Drug	Reference to Test, Test to Reference

Primary outcome

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-t)
Time frame: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t). Standard error is actually Geometric standard error.
Maximum Measured Concentration of the Analyte in Plasma (Cmax)
Time frame: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose
Maximum measured concentration of the analyte in plasma (Cmax). Standard error is actually Geometric standard error.

1 secondary outcome

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose

Results and safety

Results posted to the registry on 22 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Movalis® Capsules (T), Then Movalis® Tablets (R)	13	13
Movalis® Tablets (R), Then Movalis® Capsules (T)	13	13

Primary outcome: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-t)

Time frame: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose. Geometric least squares mean (Standard Error). Unit: Nanogram (ng)·hour (h)/ mililiter(mL)

Measure	Movalis® Capsules (T) n = 26	Movalis® Tablets (R) n = 26
Value	27870.56 (1.06)	30051.25 (1.06)

Movalis® Capsules (T) vs Movalis® Tablets (R): Geometric mean ratio T/R, %: 92.74 (95% CI 89.02 to 96.62)

Population analysed: Pharmacokinetic set (PKS): This set includes all randomised subjects who met the protocol requirements without important protocol deviation and completed all study periods.

Primary outcome: Maximum Measured Concentration of the Analyte in Plasma (Cmax)

Time frame: Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose. Geometric least squares mean (Standard Error). Unit: ng/mL

Measure	Movalis® Capsules (T) n = 26	Movalis® Tablets (R) n = 26
Value	1131.12 (1.04)	1432.83 (1.04)

Movalis® Capsules (T) vs Movalis® Tablets (R): Geometric mean ratio T/R, %: 78.94 (90% CI 73.70 to 84.56)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after the last drug administration, ie., up to 8 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Movalis® Capsules (T)	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Movalis® Tablets (R)	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Meloxicam Capsule (Test) and Meloxicam Tablet (Reference) 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 8 inclusion and 36 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 22 Nov 2019. 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 22 Nov 2019). 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 the Last Quantifiable Data Point (AUC0-t) (time frame: Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose). 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 NCT03684265.

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 22 Nov 2019.