Bioequivalence study of Gliclid 60 mg MR tablet in healthy human subjects.
- Registration Number
- CTRI/2023/02/049975
- Lead Sponsor
- The ACME Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- 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, human subject of 18-45 years (both inclusive) of age.
4 Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
• Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.
• History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
• History of severe infection or major surgery in the past 6 months.
• 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 01- Day 14
- Secondary Outcome Measures
Name Time Method Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 01- Day 14