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A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01197014
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : April 27, 2011
Information provided by:
Hanmi Pharmaceutical Company Limited

Brief Summary:

Study Design :

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine plus Losartan Drug: Amlodipine, Losartan Phase 1

Detailed Description:

Primary Objective:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official 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
Study Start Date : September 2010
Primary Completion Date : November 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Amlodipine plus Losartan Drug: Amlodipine plus Losartan
Amlodipine/Losartan high dose
Active Comparator: Amlodipine, Losartan Drug: Amlodipine, Losartan
Amlodipine, Losartan

Primary Outcome Measures :
  1. AUC, Cmax [ Time Frame: 0-144hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01197014

Czech Republic
CEPHA s.r.o.
Pilsen, Czech Republic
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

Responsible Party: Kyung-mi Park / Director, Hanmi Pharmaceutical Company Limited. Identifier: NCT01197014     History of Changes
Other Study ID Numbers: 10-ALOS-102
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: April 2011

Keywords provided by Hanmi Pharmaceutical Company Limited:
Amlodipine, Losartan

Additional relevant MeSH terms:
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists