NCT03887858

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Harnal-D Tab.	Harnal-D Tab. 1T single oral administration under fasting
DRUG	Chong Kun Dang Tamsulosin HCl Tab.	Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition

Timeline

• Start date: 2019-03-11
• Primary completion: 2019-03-22
• Completion: 2019-05-07
• First posted: 2019-03-25
• Last updated: 2020-01-30

Locations

1 site across 1 country: South Korea