Bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Rivpra Formulation Pvt. ltd., in healthy, adult, human subjects under fasting conditions.
- Registration Number
- CTRI/2023/06/054207
- Lead Sponsor
- RIVPRA FORMULATION PVT. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- 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 18.5 â?? 30 kg/m2 (both inclusive).
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: From Day-01 to Day-11
- Secondary Outcome Measures
Name Time Method Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Day-01 to Day-11