Relative bioavailability of diclofenac potassium different formulations in healthy subjects.
Phase 1
Completed
- Registration Number
- CTRI/2012/11/003106
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
1. Healthy male and female subjects
2. Subjects must weigh atleast 50 kg and their BMI should be within range of 18-30 kg/m2
3. Women of child-bearing potential must use effective contraception during the study.
Exclusion Criteria
1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
2. Pregnant or nursing (lactating) women
3. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare bioavailability of 50 mg diclofenac potassium formulations in healthy subjects under fasting conditions. <br/ ><br>Timepoint: Based on blood samples collected at multiple time points over 12 hours post dose.
- Secondary Outcome Measures
Name Time Method To assess the safety of diclofenac potassium formulations used in this study in healthy subjects.Timepoint: Monitoring of AE throughout the study