Bioequivalence of Branded and Generic Amoxicillin Capsule
- Registration Number
- CTRI/2018/01/011080
- Lead Sponsor
- Priyanka Pathak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Body Mass Index between 18.5 and 24.9 (both inclusive), calculated as weight in
kg/height in m2
Have no abnormal findings during screening within 21 days prior to administration of first
dose of study drug, medical history and examination, laboratory evaluations
Able to give written consent for participation.
1. History of major illness related to haemopoietic, renal, hepatic, endocrine, pulmonary,
central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any
other body system.
2. Smokers, who smoke 9 or more cigarettes/day and inability to abstain during the study.
3. Habituated to drinking tea, coffee (more than 5 cups/day) and inability to abstain during
the study.
4. Habituated to tobacco/tobacco containing products/gutkha (more than 10gm/day) and
inability to abstain during the study.
5. A positive result for hepatitis B, HIV antibody, Hepatitis C and syphilis [VDRL] tests.
6. History of difficulty with donating blood.
7. The receipt of an investigational product or participation in a drug research study within a
period of 90 days prior to the first of study drug.
8. History of Hypersensitivity to Amoxicillin
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method