Bioequivalence study of Uropass capsule 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) in healthy, adult, human subjects.

Completed

• Conditions: Fasting state

• Registration Number: CTRI/2023/02/049405
• Lead Sponsor: The ACME Laboratories Ltd

Brief Summary

An open label balanced randomized two treatment two period two sequence single oral dose crossover bioequivalence study of Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd in comparison with Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition

*Primary objective*

To compare the rate and extent of absorption of Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of The ACME Laboratories Ltd with that of Flomax capsuleâ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule of Sanofi Aventis in healthy adult human subjects under fasting condition

*Secondary objective*

To monitor the safety and tolerability of the study subjects after administration of Tamsulosin 0.4 mg capsules in healthy adult human subjects under fasting condition

Twenty four 24 normal healthy adult human subjects will be enrolled for the conduct of bioequivalence study

Study duration for BE study of Tamsulosin Hydrochloride 0.4 mg capsule will not exceed 9 days period I check in to last visit of period II

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-02
• Study Start: 2023-06-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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.

Exclusion Criteria

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- ∞ will be checked	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 evaluated	From baseline Day 01 to day 04 after dosing

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Harish S

Principal investigator

9900111997

harish@icbiocro.com