bioequivalence study on Bilastine 20 mg and Montelukast 10 mg tablet of Signature Phytochemical Industries
- Registration Number
- CTRI/2022/04/042108
- Lead Sponsor
- Signature Phytochemical Industries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age.
4.Body mass index in the range of 18 â??30 kg/m2 (both inclusive)
1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening.
2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs.
4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
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 1 to 12
- Secondary Outcome Measures
Name Time Method Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: from day 1 to 12