Comparative Bio availability of diclofenac sodium 75 mg per 1 ml injection as intravenous bolus in fasting human volunteers
Not Applicable
- Registration Number
- CTRI/2019/04/018583
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Body Mass Index between 18.5-30 Kg / m2 extremes included
2 Subjects with normal findings as determined by baseline history physical
examination and vital sign examination blood pressure pulse rate respiration
rate and body temperature
3 Subjects with clinically acceptable findings as determined by haemogram
biochemistry urinalysis 12 lead ECG and chest X-ray if done
Exclusion Criteria
1 Known history of hypersensitivity to Diclofenac or related drugs
2 Requiring medication for any ailment having enzyme modifying activity in the previous 28 days prior to dosing day
3 Subjects who have taken prescription medications or over the counter products
including vitamins and minerals within 14 days prior to administration of IMP
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method