NCT02186496

Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-330 (Fixed-dose Combination of Candesartan 8 mg and Amlodipine 5 mg) With Coadministration of the Two Separate Drugs in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	CKD-330 8/5mg
DRUG	Candesartan 8mg and Amlodipine 5mg

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2014-07-10
• Last updated: 2014-12-02

Locations

1 site across 1 country: South Korea