A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Phase 1CompletedNCT01197001

Hanmi Pharmaceutical Company Limited72 enrolled

Overview

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

Secondary Objective: * To evaluate the safety and tolerability of these formulations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Amlodipine plus LosartanDRUG

Amlodipine/Losartan low dose

Amlodipine, LosartanDRUG

Amlodipine, Losartan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CEPHA s.r.o.

Pilsen, Czechia

Outcomes

Primary Outcomes

AUC, Cmax

Time frame: 0-144hrs

Data from ClinicalTrials.gov

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