NCT03382756

A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337

A Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 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 – 45 Years
• Healthy volunteers: Accepted

Summary

A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects

Detailed description

This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337. Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337. Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa. Each treatment period was separated by a washout period of at least 7 days.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High fat diet	A diet consisting of more than 900kcal and 35% of fat
DRUG	CKD-337	Test Drug

Timeline

• Start date: 2017-10-12
• Primary completion: 2017-11-02
• Completion: 2017-11-07
• First posted: 2017-12-26
• Last updated: 2017-12-27

Locations

1 site across 1 country: South Korea