- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197014
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
April 26, 2011 updated by: Hanmi Pharmaceutical Company Limited
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 Design :
- A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pilsen, Czech Republic
- CEPHA s.r.o.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amlodipine plus Losartan
|
Amlodipine/Losartan high dose
|
Active Comparator: Amlodipine, Losartan
|
Amlodipine, Losartan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC, Cmax
Time Frame: 0-144hrs
|
0-144hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 7, 2010
First Submitted That Met QC Criteria
September 7, 2010
First Posted (Estimate)
September 9, 2010
Study Record Updates
Last Update Posted (Estimate)
April 27, 2011
Last Update Submitted That Met QC Criteria
April 26, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Losartan
Other Study ID Numbers
- 10-ALOS-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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