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A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

NCT01197001 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-04-27

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

Amlodipine plus Losartan

Amlodipine/Losartan low dose

DRUG

Amlodipine, Losartan

Amlodipine, Losartan

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197001 on ClinicalTrials.gov