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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197001

Enrollment

Registered

2010-09-09

Start date

2010-08-31

Completion date

2010-11-30

Last updated

2011-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Amlodipine, Losartan

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.

Interventions

DRUGAmlodipine plus Losartan

Amlodipine/Losartan low dose

DRUGAmlodipine, Losartan

Amlodipine, Losartan

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUC, Cmax	0-144hrs

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026