NCT02358824

CKD-828 (80/5mg) Pharmacokinetic Study

A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, single-dose, four-period, two-way, crossover study,

Detailed description

A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	CKD-828	Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period)
DRUG	Telmisartan	\- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period)
DRUG	S-amlodipine	\- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period)

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-02-09
• Last updated: 2015-07-08

Locations

1 site across 1 country: South Korea