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Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets

NCT06289881 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-04

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Sildenafill-Test product

Test-Product: Sildenafil 100 mg tablets Manufactured by: Actigen Co., Ltd., Thailand

DRUG

Sildenafill-Reference product

Reference-product: Viagra 100 mg tablets Manufactured by: FAREVA AMBOISE, France

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-02-04
Primary Completion
2025-03-11
Completion
2025-03-25

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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 NCT06289881 on ClinicalTrials.gov