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

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 capsuleï?¢ 0.4 mg (Tamsulosin Hydrochloride 0.4 mg capsule) of Sanofi-Aventis in healthy, adult, human subjects under fasting condition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049405
Enrollment
24
Registered
2023-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Uropass capsule 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule: Single oral dose Control Intervention1: Flomax capsuleï?¢ 0.4 mg Tamsulosin Hydrochloride 0.4 mg capsule: Single oral dos

Sponsors

The ACME Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 30 kg/m2 both inclusive 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician

Exclusion criteria

Exclusion criteria: 1 Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood 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 7 Any other clinical condition like diarrhea or vomiting within three days prior to check in of any period

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters Cmax AUC0-t and AUC0- â?? will be checkedTimepoint: From baseline Day 01 to day 10 after the dosing—

Secondary

MeasureTime frame
Pharmacokinetic parameters as Tmax AUC_%Extrap_obs λz and t1/2 will be evaluatedTimepoint: From baseline Day 01 to day 04 after dosing—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com9900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026