Bioequivalence study of Esomeprazole 40 mg MUPS tablets of SunGlow Lifescience Private Ltd with Nexium mups 40 mg gastro resistant tablets (Esomeprazole) of Grunenthal GmbH in healthy adult human subjects under fasting conditions
- Registration Number
- CTRI/2024/07/071741
- Lead Sponsor
- SunGlow Lifescience Private 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 – 30 kg/m2 (both inclusive).
5. Healthy volunteers who are clinically non anemic will be included as per the discretion of
PI/CI/Physician.
1. Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for
women.
2. Any medical or surgical condition, which might significantly interfere with the functioning
of the gastrointestinal tract or blood–forming organs.
3. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime
in the past.
4. History of severe infection or major surgery in the past 6 months.
5. 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 To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-8Timepoint: From Day 01 to Day 09
- Secondary Outcome Measures
Name Time Method To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, ?z and t1/2Timepoint: From Day 01 to Day 09