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A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)

NCT02519010 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-10

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets (Pharmacare, Palestine) and Exforge 10/160 film coated tablets (Novartis Pharma, USA).

Conditions

  • Healthy

Interventions

DRUG

Amlodipine/Valsartan

1 tablet contains Amlodipine 10 mg \&valsartan 160 mg

DRUG

Exforge

1 tablet contains Amlodipine 10 mg \&valsartan 160 mg

Sponsors & Collaborators

  • Pharmacare PLC, Palestine

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

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
2011-03-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Egypt

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 NCT02519010 on ClinicalTrials.gov