bioequivalence study of Posaconazole 100 mg gastro-resistant tablets of Signature Phytochemical Industries
- Registration Number
- CTRI/2022/06/043016
- Lead Sponsor
- Signature Phytochemical Industries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
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).
5 Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female.
1 Found positive (+ve) on rapid 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.
5 History of severe infection or major surgery in the past 6 months.
6 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, and AUC0-72Timepoint: From day 1 and day 19
- Secondary Outcome Measures
Name Time Method Tmax, λz and t1/2Timepoint: From day 1 and day 19