Bioequivalence study of Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) in healthy, adult, human subjects.
- Registration Number
- CTRI/2023/02/049405
- Lead Sponsor
- The ACME Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
2Willing to be available for the entire study period and to comply with protocol requirements
3Normal healthy adult human subject of 18 45 years both inclusive of age
4Body mass index in the range of 18 30 kg/m2 both inclusive
5Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician
1Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs
2History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past
3History of severe infection or major surgery in the past 6 months
4History of Minor surgery or fracture within the past 3 months
5Significant 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
6Any major illness or hospitalization within 90 days prior to check in of first period
7Any other clinical condition like diarrhea or vomiting within three days prior to check in of any period
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters Cmax AUC0-t and AUC0- â?? will be checkedTimepoint: From baseline Day 01 to day 10 after the dosing
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters as Tmax AUC_%Extrap_obs λz and t1/2 will be evaluatedTimepoint: From baseline Day 01 to day 04 after dosing