NCT01926652

Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	candesartan cilexetil 32mg, amlodipine 10mg	Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-08-21
• Last updated: 2013-08-21

Locations

1 site across 1 country: South Korea