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OpenTrials
Completed

NCT Number: NCT01197001

A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CEPHA s.r.o.

Pilsen, CZ-323 00, Czechia

About this study

Secondary Objective:

  • To evaluate the safety and tolerability of these formulations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amlodipine plus Losartan

Drug

Amlodipine/Losartan low dose

Amlodipine, Losartan

Drug

Amlodipine, Losartan

Primary outcomes

  1. AUC, Cmax

    Time frame: 0-144hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2010
Registry last updated
Apr 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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