A Phase 1 Two-Part Study to Evaluate the Pharmacokinetics and Safety of a 7-Day Tamsulosin Transdermal Delivery System (TDS) in Healthy Male Volunteers

Phase 1

• Conditions: benign prostatic hyperplasia; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12612000485831
• Lead Sponsor: Corium International, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

healthy male volunteers aged 18-40
normal findings in ECG and physical exam
normal clinical laboratory values

Exclusion Criteria

allergy or intolerance to tamsulosin
orthostatic hypotension
history of alcohol or drug abuse
prescription or OTC drug use in 2 weeks prior to screening
hemoglobin less than 130 gm/m

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma concentrations of tamsulosin[6,12,18,24,30,36,48,60,72,84,96,108,120,132,144,156,168,172,180,192,216,240 hours after TDS application]

Secondary Outcome Measures

Name	Time	Method
Safety and local tolerability following TDS application[hourly vital signs through 12 hours after TDS application and then every 4-6 hours until removal. Skin sites assessed for irritation 4,12,24,48 hours after TDS removal];safety following oral tamsulosin administration[hourly vital signs after tamsulosin capsule dosing throgh 12 hours, and then every 4-6 hours through 60 hours post-dose]