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:
NCT01197001
First received: September 7, 2010
Last updated: April 26, 2011
Last verified: April 2011
  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
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:


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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197001

Locations
Czech Republic
CEPHA s.r.o.
Pilsen, Czech Republic, CZ-323 00
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: NCT01197001     History of Changes
Other Study ID Numbers: 10-ALOS-101
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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014