Bioequivalence study ofSildenafil 100 mg and Dapoxetine 60 mg oral jelly 5 gm in helthy adult subjects under fasting conditions.
- Registration Number
- CTRI/2022/12/048362
- Lead Sponsor
- HAB Pharmaceuticals and Research Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Able to comprehend the nature and purpose of the study and willing to give
written informed consent for participation in the study
2. Willing to be available for the entire study period and to comply with
protocol requirements.
3. Normal, healthy, adult, male subject of 18-45 years of age.
4. Body mass index in the range of 18 â?? 30 kg/m2.
5. Healthy volunteers who are clinically non anemic will be included as per
the discretion of PI/CI/Physician.
1. Any medical or surgical condition, which might significantly interfere with
the functioning of the gastrointestinal tract or bloodâ??forming organs.
2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in
stools anytime in the past.
3. History of severe infection or major surgery in the past 6 months.
4.History of Minor surgery or fracture within the past 3 months.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-t and AUC0-â??Timepoint: day 1 to day 9
- Secondary Outcome Measures
Name Time Method Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: day 1 to day 9