NCT01197001

A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine plus Losartan	Amlodipine/Losartan low dose
DRUG	Amlodipine, Losartan	Amlodipine, Losartan

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2010-09-09
• Last updated: 2011-04-27

Locations

1 site across 1 country: Czechia