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Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg

NCT06553924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-14

No results posted yet for this study

Summary

Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.

Conditions

Interventions

DRUG

Macitentan and Tadalafil film-coated tablets

1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg

DRUG

PrOpsynvi® macitentan and tadalafil film-coated tablets

1 tablet of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

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
2024-05-14
Primary Completion
2024-05-31
Completion
2024-08-08

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT06553924 on ClinicalTrials.gov