NCT01838967

A Drug Interaction Study of Cilnidipine and Valsartan

A Randomized, Open-label, Single Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Cilnidipine 10 mg and Valsartan 160 mg After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between Cilnidipine 10 mg and Valsartan 160 mg in healthy male volunteers who receive Cilnidipine 10 mg alone, Valsartan 160 mg , and both together in a 3 period repeatedly.

Detailed description

To evaluate the safety, drug-tolerance, pharmacokinetics of Cilnidipine 10 mg or Valsartan 160 mg monotherapy or Cilnidipine 10 mg and Valsartan 160 mg combination in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	C - V - C+V	Drug will be administered to according to C - V - C+V sequence for 3 period.
DRUG	C - C+V - V	Drug will be administered to according to C - C+V - V sequence for 3 period.
DRUG	V - C - C+V	Drug will be administered to according to V - C - C+V sequence for 3 period.
DRUG	V - C+V - C	Drug will be administered to according to V - C+V - C sequence for 3 period.
DRUG	C+V - C - V	Drug will be administered to according to C+V - C - V sequence for 3 period.
DRUG	C+V - V - C	Drug will be administered to according to C+V - V - C sequence for 3 period.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-06-01
• Completion: 2013-10-01
• First posted: 2013-04-24
• Last updated: 2013-10-14

Locations

1 site across 1 country: South Korea