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Bioequivalence Study of Amlodipine/Valsartan 10/160 mg Film Coated Tablets

NCT06193044 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-01-09

No results posted yet for this study

Summary

Comparative randomized, Single dose, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA).

Conditions

  • Healthy Volunteer

Interventions

DRUG

Amlodipine/Valsartan

Amlodipine 10 mg \&valsartan 160 mg

DRUG

Amlodipine 10 mg &valsartan 160 mg (Exforge)

Amlodipine 10 mg \&valsartan 160 mg

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Porranee Puranajoti, Prof. · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2024-07-09
Completion
2024-07-12

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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 NCT06193044 on ClinicalTrials.gov