NCT02615782

A Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 in Healthy Male Subjects

A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 After a Single Oral Dose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects

Detailed description

To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days. Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.

Conditions

• Benign Prostatic Hypertrophy (BPH)

Interventions

Type	Name	Description
DRUG	CKD-397	CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2015-11-26
• Last updated: 2017-08-09

Locations

1 site across 1 country: South Korea