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A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01197001
First Posted: September 9, 2010
Last Update Posted: April 27, 2011
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.
Information provided by:
Hanmi Pharmaceutical Company Limited
  Purpose

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

Condition Intervention Phase
Healthy Drug: Amlodipine plus Losartan Drug: Amlodipine, Losartan Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

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

Estimated Enrollment: 72
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlodipine plus Losartan Drug: Amlodipine plus Losartan
Amlodipine/Losartan low dose
Active Comparator: Amlodipine, Losartan Drug: Amlodipine, Losartan
Amlodipine, Losartan

Detailed Description:

Secondary Objective:

  • To evaluate the safety and tolerability of these formulations.
  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01197001


Locations
Czech Republic
CEPHA s.r.o.
Pilsen, Czech Republic, CZ-323 00
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Kyung-mi Park / Director, Hanmi Pharmaceutical Company Limited.
ClinicalTrials.gov Identifier: NCT01197001     History of Changes
Other Study ID Numbers: 10-ALOS-101
First Submitted: September 7, 2010
First Posted: September 9, 2010
Last Update Posted: April 27, 2011
Last Verified: April 2011

Keywords provided by Hanmi Pharmaceutical Company Limited:
Amlodipine, Losartan

Additional relevant MeSH terms:
Amlodipine
Losartan
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