Healthy SubjectsPhase 1NCT03642873

Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate

A Phase 1 study testing Humibid®, Hydrocodone Bitartrate and Humibid® and Hydrocodone Bitartrate tablet in people with Healthy Subjects, run by Reckitt Benckiser LLC.

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

Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Humibid®, Hydrocodone Bitartrate and Humibid® and Hydrocodone Bitartrate tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 5 May 2007to 21 May 2007
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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and/or females between the ages of 19 and 55 years, inclusive.
Females of childbearing potential were using one of the following acceptable birth control methods:
Intrauterine device (IUD) in place for at least 3 months prior to study;
Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through 30 days beyond study completion;
Stable hormonal contraceptive for at least 3 months prior to study through 30 days beyond completion of study;
Abstinence was not an acceptable form of contraception.

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Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.
Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.
Within 15% of Ideal Body Weight as defined by the 1983 Metropolitan Life chart.
Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 1 year.
Able to read, understand, and sign the informed consent after the nature of the study had been explained.
Negative finding on tests for Hepatitis B and C antigen as well as HIV and pregnancy test (if female).
Negative urine screen for drugs of abuse and alcohol at screening and the first check in.
Non-alcohol or drug abuser - for alcohol, defined as history of less then 4 drinks daily.

Who cannot join

Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
Females who were pregnant or nursing.
History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
Receipt of an investigational drug within 1 month prior to study enrollment.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.
Known or suspected use of illicit drugs (including codeine or hydrocodone, etc.).

Show all 10Show fewer

The use of any medication on a chronic basis with the exception of oral contraceptives for women of childbearing potential. An appropriate drug-free period for prescription or over-the-counter (OTC) drugs provided to washout any especially long half-life drugs.
Consumption of alcohol within 48 hours prior to each dosing period.
Consumption of grapefruit 14 days prior to dosing and throughout the study.
Hemoglobin value < 12 g/dL. If a subject's hemoglobin dropped below 11.0 g/dL the subject was dropped from the study at the Principal Investigator's discretion.

About this study

Official title: A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers

Conditions: Healthy Subjects
Being tested: Humibid®, Hydrocodone Bitartrate, Humibid® and Hydrocodone Bitartrate tablet

What participants receive

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

Humibid®Drug
Also called Guaifenesin
Humibid® 1200 mg (single extended release) tablet
Hydrocodone BitartrateDrug
Hydrocodone Bitartrate (3.33 mg q4h X 3)
Humibid® and Hydrocodone Bitartrate tabletDrug
Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)

Study groups in NCT03642873
Study group	Role	What they receive
Treatment A	Experimental	Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions. Receives: Drug: Humibid®
Treatment B	Experimental	Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state. Receives: Drug: Hydrocodone Bitartrate
Treatment C	Experimental	Hydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state. Receives: Drug: Humibid® and Hydrocodone Bitartrate tablet

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Pharmacokinetic Parameter Cmax (Maximum measured plasma concentration)
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Pharmacokinetic Parameter AUC(0-t) The area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
The area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/ Kel, where Ct is the last measurable concentration.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Pharmacokinetic Parameter (Tmax) Time of the maximum measured plasma concentration.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Apparent Terminal Elimination Half-life (T1/2) of Guaifenesin
Apparent first-order terminal elimination half-life was calculated as 0.693/Kel.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose

Secondary outcomes (1)

Number of Adverse Events(AEs) Experienced by Participants
Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.
Mild = AE did not limit usual activities; subject may have experienced slight discomfort.
Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.
Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/ pain.
Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Measured: Upto Day 17

Timeline

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

5 May 200721 May 2007

First posted22 Aug 2018
Study start5 May 2007
Primary completion21 May 2007
Study completion21 May 2007

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 Healthy SubjectsStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03642873
Sponsor's protocol ID: 2006-HYDRO-04
Status last verified: Mar 2019
First submitted: 20 Aug 2018
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers
ClinicalTrials.gov ID: NCT03642873
Acronym / sponsor ID: 2006-HYDRO-04
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
Study start: 5 May 2007 (actual)
Primary completion: 21 May 2007 (actual)
Study completion: 21 May 2007 (actual)
First posted: 22 Aug 2018 (actual)
Results: Posted 20 Jun 2019

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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment A	Experimental	Drug: Humibid®Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions.
Treatment B	Experimental	Drug: Hydrocodone BitartrateHydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state.
Treatment C	Experimental	Drug: Humibid® and Hydrocodone Bitartrate tabletHydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Males and/or females between the ages of 19 and 55 years, inclusive.
Females of childbearing potential were using one of the following acceptable birth control methods:
Abstinence was not an acceptable form of contraception.
Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 3 months prior to study) or postmenopausal <2 years. An FSH >40 mIU/mL was obtained and in the record.
Good general health was determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measures.

Key exclusion criteria (10 listed)

Clinically significant abnormalities detected by medical history, physical, ECG, or clinical laboratory findings (as determined by the Principal Investigator). Any disease or condition which impacted absorption, distribution, metabolism, or elimination of the study drugs.
Females who were pregnant or nursing.
History of hypersensitivity reaction to the study drugs or related compounds, such as other opioids.
Receipt of an investigational drug within 1 month prior to study enrollment.
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior study enrollment.

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
Humibid®Also: GuaifenesinHumibid® 1200 mg (single extended release) tablet	Drug	Treatment A
Hydrocodone BitartrateHydrocodone Bitartrate (3.33 mg q4h X 3)	Drug	Treatment B
Humibid® and Hydrocodone Bitartrate tabletHumibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)	Drug	Treatment C

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Pharmacokinetic Parameter Cmax (Maximum measured plasma concentration)
Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Pharmacokinetic Parameter AUC(0-t) The area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration.
Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
The area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/ Kel, where Ct is the last measurable concentration.
Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase.
Time to Maximum Observed Concentration (Tmax) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Pharmacokinetic Parameter (Tmax) Time of the maximum measured plasma concentration.
Apparent Terminal Elimination Half-life (T1/2) of Guaifenesin
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose
Apparent first-order terminal elimination half-life was calculated as 0.693/Kel.

1 secondary outcome

Number of Adverse Events(AEs) Experienced by Participants
Time frame: Upto Day 17

Results and safety

Results posted to the registry on 20 Jun 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
Sequence ABC	4	4
Sequence ACB	4	4
Sequence BAC	4	4
Sequence BCA	4	4
Sequence CAB	4	4
Sequence CBA	4	4

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Guaifenesin

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A (Reference) - Plasma Guaifenesin n = 24	Treatment C (Test) - Plasma Guaifenesin n = 24	Treatments B (Reference) - Plasma Hydrocodone Bitartrate n = 23	Treatment C (Test) - Plasma Hydrocodone Bitartrate n = 24
Value	1770 (628)	1810 (784)	11.3 (2.14)	11.3 (1.78)

Population analysed: Pharmacokinetic (PK) Data Sets included all the 24 subjects for analysis.

Primary outcome: Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Treatment A (Reference) - Plasma Guaifenesin n = 24	Treatment C (Test) - Plasma Guaifenesin n = 24	Treatments B (Reference) - Plasma Hydrocodone Bitartrate n = 23	Treatment C (Test) - Plasma Hydrocodone Bitartrate n = 24
Value	8286.2 (2440.0)	8186.7 (2801.0)	133.36 (29.407)	132.99 (23.053)

Population analysed: Pharmacokinetic (PK) Data Sets

Primary outcome: Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Treatment A (Reference) - Plasma Guaifenesin n = 20	Treatment C (Test) - Plasma Guaifenesin n = 21	Treatments B (Reference) - Plasma Hydrocodone Bitartrate n = 23	Treatment C (Test) - Plasma Hydrocodone Bitartrate n = 24
Value	8501.5 (2784.5)	8347.8 (2762.4)	140.44 (32.792)	139.70 (26.044)

Population analysed: Pharmacokinetic (PK) Data Sets

Primary outcome: Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose. Mean (Standard Deviation). Unit: 1/hr

Measure	Treatment A (Reference) - Plasma Guaifenesin n = 20	Treatment C (Test) - Plasma Guaifenesin n = 21	Treatments B (Reference) - Plasma Hydrocodone Bitartrate n = 23	Treatment C (Test) - Plasma Hydrocodone Bitartrate n = 24
Value	0.205 (0.104)	0.207 (0.199)	0.151 (0.0251)	0.155 (0.0233)

Population analysed: Pharmacokinetic (PK) Data Sets

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 17. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Treatment B	0 of 23 (0%)	10 of 23 (43.5%)	0 of 23
Treatment C	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Humibid®, Hydrocodone Bitartrate and Humibid® and Hydrocodone Bitartrate tablet in people with Healthy Subjects, run by Reckitt Benckiser LLC.

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 14 inclusion and 10 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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 20 Jun 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?

Maximum Observed Plasma Concentration (Cmax) of Guaifenesin (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose). The study lists 6 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 NCT03642873.

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 20 Jun 2019.