A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

NCT ID: NCT01197014

Last Updated: 2011-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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Study Design :

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

Detailed Description

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Primary Objective:

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Amlodipine plus Losartan

Group Type EXPERIMENTAL

Amlodipine plus Losartan

Intervention Type DRUG

Amlodipine/Losartan high dose

Amlodipine, Losartan

Group Type ACTIVE_COMPARATOR

Amlodipine, Losartan

Intervention Type DRUG

Amlodipine, Losartan

Interventions

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Amlodipine plus Losartan

Amlodipine/Losartan high dose

Intervention Type DRUG

Amlodipine, Losartan

Amlodipine, Losartan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Hanmi Pharmaceutical Company Limited.

Locations

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CEPHA s.r.o.

Pilsen, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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10-ALOS-102

Identifier Type: -

Identifier Source: org_study_id

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