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Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Benign Prostatic Hyperplasia Clinical Trial

Official title:
An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Clinical Trial Summary

This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

Clinical Trial Description

To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03887858
Study type Interventional
Source Chong Kun Dang Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date March 11, 2019
Completion date May 7, 2019
View Details
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