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Bioequivalence of Branded and Generic Amoxicillin Capsule

Comparison of Chemical and Biological equivalence of Branded and Generic Amoxicillin Capsule

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011080
Enrollment
12
Registered
2018-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Amoxicillin: 500 mg, Capsule, Oral administration, Single dose administration on day of trial Control Intervention1: Amoxicillin: 500 mg, Capsule, Oral administration, Single dose admin

Sponsors

Priyanka Pathak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
NATimepoint: NA

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactPriyanka Pathak

Maharashtra Medical Council

drvpandit@yahoo.co.in9371003390

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026