bioequivalence study of Ibuprofen sodium dihydrate 512 mg tablets in healthy, adult, human subjects under Fed conditions
- Registration Number
- CTRI/2022/07/044135
- Lead Sponsor
- yrus Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
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 of >=18.5 kg/m2 and <= 30.0 kg/m2, with body weight not less than 60 kg. (Both inclusive).
5.Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician
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.
5.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
6.Any major illness or hospitalization within 90 days prior to check-in of first period.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the Cmax, AUC0-t and AUC0-â??Timepoint: From Period-I to Period II for 9 Days
- Secondary Outcome Measures
Name Time Method Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Period-I to Period II for 9 Days