A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197014
• Other study ID #: 10-ALOS-102
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2010
• Last updated: April 26, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

Study Design :

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

Description:

Primary Objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Amlodipine plus Losartan
Amlodipine/Losartan high dose
• Amlodipine, Losartan
Amlodipine, Losartan

Locations

Country	Name	City	State
Czech Republic	CEPHA s.r.o.	Pilsen

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC, Cmax		0-144hrs	No