Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions
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ClinicalTrials.gov Identifier: NCT00778544 |
Recruitment Status
:
Completed
First Posted
: October 23, 2008
Last Update Posted
: October 23, 2008
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Tracking Information | |||
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First Submitted Date ICMJE | October 22, 2008 | ||
First Posted Date ICMJE | October 23, 2008 | ||
Last Update Posted Date | October 23, 2008 | ||
Study Start Date ICMJE | June 2006 | ||
Actual Primary Completion Date | July 2006 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Bioequivalence | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions | ||
Official Title ICMJE | Randomized, Open-Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg- 42.9 mg/ 5 mL Oral Suspension and Augmentin ES-600 (Reference) Following a 600 mg- 42.9 mg Dose in Healthy Subjects Under Fed Conditions. | ||
Brief Summary | The objective of this study was to compare the rate and extent of absorption of Ranbaxy Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A. (Augmentin ES-600), amoxicillin-clavulanic acid, administered as a 1 x 5 mL (600 mg - 42.9 mg) oral suspension, under fed conditions. | ||
Detailed Description | This was a single center, randomized, single-dose, open label, 2 - way crossover bioequivalence study to compare the rate and extent of absorption of a test amoxicillin-clavulanic acid versus Augmentin ES-600, a reference amoxicillin- clavulanic acid, under fed conditions. Prior to the study commencement, subjects were randomly assigned to a treatment in accordance with the randomization scheme generated by Anapharm. Subjects were confined to the Anapharm Clinical research Facility from at least 11 hours prior to drug administration until after the 12.0 hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 14 days. A total of sixty-two (62) healthy adult subjects signed the study specific informed consent form and were confined for period I; of these subjects forty eight (48), (21 males and 27 females) were enrolled and dosed in the study; forty six (46) of these enrolled subjects completed the clinical phase of the study |
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Study Type ICMJE | Interventional | ||
Study Phase | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
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Condition ICMJE | Healthy | ||
Intervention ICMJE | Drug: amoxicillin-clavulanic acid 600 mg- 42.9 mg/ 5 mL oral suspension | ||
Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
48 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | September 2006 | ||
Actual Primary Completion Date | July 2006 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00778544 | ||
Other Study ID Numbers ICMJE | 60250 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Dr. Tausif Monif, Ranbaxy Research Labs | ||
Study Sponsor ICMJE | Ranbaxy Laboratories Limited | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Ranbaxy Inc. | ||
Verification Date | October 2008 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |