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A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01197014
First received: September 7, 2010
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

Study Design :

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUC, Cmax [ Time Frame: 0-144hrs ] [ Designated as safety issue: No ]

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

Detailed Description:

Primary Objective:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197014

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

No publications provided

Responsible Party: Kyung-mi Park / Director, Hanmi Pharmaceutical Company Limited.
ClinicalTrials.gov Identifier: NCT01197014     History of Changes
Other Study ID Numbers: 10-ALOS-102
Study First Received: September 7, 2010
Last Updated: April 26, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Hanmi Pharmaceutical Company Limited:
Amlodipine, Losartan

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

ClinicalTrials.gov processed this record on May 21, 2013