A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Amlodipine plus Losartan; Drug: Amlodipine, Losartan

• Registration Number: NCT01197001
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

Study Design :

* A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

* To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Detailed Description

Secondary Objective:

* To evaluate the safety and tolerability of these formulations.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-09
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-26
• Last Update Posted: 2011-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Age 18-55 years
• Healthy Caucasian volunteers
• Non smokers or mild smokers

Exclusion criteria:

• Pregnancy and/or breast-feeding
• Participation in another clinical trial within 60 days prior to Period 1.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amlodipine plus Losartan	Amlodipine plus Losartan	-
Amlodipine, Losartan	Amlodipine, Losartan	-

Primary Outcome Measures

Name	Time	Method
AUC, Cmax	0-144hrs

Trial Locations

Locations (1)

CEPHA s.r.o.; 🇨🇿 Pilsen, Czech Republic