HealthyPhase 1NCT00835705

Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions

A Phase 1 study testing amoxicillin-clavulanic acid and Augmentin® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: amoxicillin-clavulanic acid and Augmentin®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteCanada
Study dates: Sep 2003to Sep 2003
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will be females and/or males, non-smokers, 18 years of age and older.

Who cannot join

Subjects to whom any of the following applies will be excluded from the study:
Clinically significant illnesses within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.

Show all 35Show fewer

Positive urine drug screen at screening.
Positive testing for hepatitis B, hepatitis C or HIV at screening.
ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.
Subjects with BMI ≥30.0.
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid or other related drugs (e.g. penicillin, cephalosporins, cephamycins).
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid)
use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Subinvestigator, contraindicate the subject's participation in this study.
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products )including natural products, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
Less than 300 mL of whole blood within 30 days or
300 mL to 500 mL of whole blood within 45 days or
more than 500 mL of whole blood within 56 days.
Positive alcohol breath test at screening.
Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
Intolerance to venipunctures
Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction
Any known active mononucleosis
Subjects with dentures or braces.
Additional exclusion criteria for female subjects only:
Breast feeding subjects.
Positive urine pregnancy test at screening (performed on all females).

Trial locations and contacts

1 site in 1 country.

Canada1 site

Anapharm Inc.
Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: amoxicillin-clavulanic acid, Augmentin®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

amoxicillin-clavulanic acidDrug
400 mg-57 mg chewable tablet
Augmentin®Drug
400 mg-57 mg chewable tablet

Study groups in NCT00835705
Study group	Role	What they receive
Amoxicillin Clavulanic Acid	Experimental	Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 400-57 mg Chewable Tablet (reference) dosed in second period Receives: Drug: amoxicillin-clavulanic acid
Augmentin®	Active comparator	Augmentin® 400-57 mg Chewable Tablet (reference) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in second period Receives: Drug: Augmentin®

What is being measured

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

Cmax (Maximum Observed Concentration) - Amoxicillin
Bioequivalence based on Cmax
Measured: Blood samples were collected over 10 hour period
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
Bioequivalence based on AUC0-inf
Measured: Blood samples were collected over 10 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Bioequivalence based on AUC0-t
Measured: Blood samples were collected over 10 hour period
Cmax (Maximum Observed Concentration) - Clavulanic Acid
Bioequivalence based on Cmax
Measured: Blood samples collected over 10 hour period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 10 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 10 hour period

Timeline

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

Sep 2003Sep 2003

First posted4 Feb 2009 (estimated)
Study startSep 2003
Primary completionSep 2003
Study completionSep 2003

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.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00835705
Sponsor's protocol ID: 30073
Status last verified: Aug 2024
First submitted: 2 Feb 2009
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT00835705
Acronym / sponsor ID: 30073
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Sep 2003 (actual)
Study completion: Sep 2003 (actual)
First posted: 4 Feb 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

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

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

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

Arm	Type	Receives
Amoxicillin Clavulanic Acid	Experimental	Drug: amoxicillin-clavulanic acidAmoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 400-57 mg Chewable Tablet (reference) dosed in second period
Augmentin®	Active comparator	Drug: Augmentin®Augmentin® 400-57 mg Chewable Tablet (reference) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in second period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects will be females and/or males, non-smokers, 18 years of age and older.

Key exclusion criteria (35 listed)

Clinically significant illnesses within 4 weeks of the administration of study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Any clinically significant abnormality found during medical screening.
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.

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
amoxicillin-clavulanic acid400 mg-57 mg chewable tablet	Drug	Amoxicillin Clavulanic Acid
Augmentin®400 mg-57 mg chewable tablet	Drug	Augmentin®

Primary outcome

Cmax (Maximum Observed Concentration) - Amoxicillin
Time frame: Blood samples were collected over 10 hour period
Bioequivalence based on Cmax
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
Time frame: Blood samples were collected over 10 hour period
Bioequivalence based on AUC0-inf
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Time frame: Blood samples were collected over 10 hour period
Bioequivalence based on AUC0-t
Cmax (Maximum Observed Concentration) - Clavulanic Acid
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on Cmax
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-inf
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
Time frame: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amoxicillin Clavulanic Acid (Test) First	24	23
Augmentin® (Reference) First	28	28

Primary outcome: Cmax (Maximum Observed Concentration) - Amoxicillin

Time frame: Blood samples were collected over 10 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Amoxicillin Clavulanic Acid n = 50	Augmentin® n = 50
Value	7800.48 (2113.68)	7599.29 (2222.97)

Amoxicillin Clavulanic Acid vs Augmentin®: Ratio of Least Squares Means: 103.03 (90% CI 98.40 to 107.88)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin

Time frame: Blood samples were collected over 10 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Amoxicillin Clavulanic Acid n = 50	Augmentin® n = 50
Value	19089.36 (3440.49)	19395.97 (3670.87)

Amoxicillin Clavulanic Acid vs Augmentin®: Ratio of Least Squares Means: 98.43 (90% CI 96.71 to 100.18)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin

Time frame: Blood samples were collected over 10 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Amoxicillin Clavulanic Acid n = 50	Augmentin® n = 50
Value	18939.13 (3441.02)	19263.26 (3640.51)

Amoxicillin Clavulanic Acid vs Augmentin®: Ratio of Least Squares Means: 98.29 (90% CI 96.58 to 100.03)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: Cmax (Maximum Observed Concentration) - Clavulanic Acid

Time frame: Blood samples collected over 10 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Amoxicillin Clavulanic Acid n = 50	Augmentin® n = 50
Value	1483.32 (508.73)	1449.68 (497.08)

Amoxicillin Clavulanic Acid vs Augmentin®: Ratio of Least Squares Means: 103.16 (90% CI 95.33 to 111.64)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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.

Benoit Girard, MD principal investigator

Anapharm

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 amoxicillin-clavulanic acid and Augmentin® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 1 inclusion and 35 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 Aug 2024. 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 Canada. 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 18 Aug 2009). 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?

Cmax (Maximum Observed Concentration) - Amoxicillin (time frame: Blood samples were collected over 10 hour period). 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 NCT00835705.

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 Aug 2024.