Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions
Tracking Information | |
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First Received Date ICMJE | April 9, 2009 |
Last Updated Date | April 9, 2009 |
Start Date ICMJE | January 2007 |
Primary Completion Date | January 2007 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Bioequivalence evaluation of Ranbaxy Ramipril 10mg Capsules under fasting conditions [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions |
Official Title ICMJE | An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover, Bioavailability Study Comparing Ramipril 10 mg Capsules of OHM Laboratories Inc (a Subsidiary of Ranbaxy Pharmaceuticals Inc) With ALTACE® 10 mg Capsules (Containing Ramipril 10 mg) of King Pharmaceuticals Inc, in Healthy, Adult, Male Human Subjects Under Fasting Condition. |
Brief Summary | The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg of OHM Laboratories Inc., USA with ALTACE® (ramipril) capsule 10 mg manufactured by King Pharmaceuticals Inc., Bristol, TN 37620, USA in healthy, adult, male, human subjects under fasting condition. |
Detailed Description | Following an overnight fast of at least 10 hour, a single oral dose of ramipril 10 mg capsule was administered during each period of the study, along with 240 mL of drinking water at ambient temperature, under low light condition and supervision of trained study personnel. A total of sixty-eight (68) subjects were enrolled into the study, to be administered a single oral dose of the test or reference formulation of ramipril 10 mg capsule according to a randomization schedule. Two subjects (subject numbers 01 and 06) were withdrawn from the study in period I and subject number 02 did not report for period II. Sixty-five (65) subjects completed both the periods of the study. |
Study Type ICMJE | Interventional |
Study Phase | |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
Condition ICMJE | Healthy |
Intervention ICMJE | Drug: Ramipril 10mg capsules |
Study Arm (s) |
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Publications * | |
* 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 |
Enrollment ICMJE | 68 |
Completion Date | March 2007 |
Primary Completion Date | January 2007 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male |
Ages | 18 Years to 45 Years |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | India |
Administrative Information | |
NCT Number ICMJE | NCT00879476 |
Other Study ID Numbers ICMJE | 245_RAMIP_06 |
Has Data Monitoring Committee | Yes |
Responsible Party | Dr. Tausif Monif, Ranbaxy Research Laboratories |
Study Sponsor ICMJE | Ranbaxy Laboratories Limited |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Ranbaxy Inc. |
Verification Date | April 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |