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Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets

NCT06180096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-28

No results posted yet for this study

Summary

Single dose oral bioequivalence study of Riociguat 2.5 mg film coated tablets and 'Adempas' (Riociguat) 2.5 mg Filmtabletten (film coated tablets) in healthy adult male subjects under fasting conditions.

Conditions

Interventions

DRUG

Riociguat film coated tablets

1 tablet of 2.5 mg Riociguat

DRUG

Adempas Filmtabletten

1 tablet of 2.5 mg Riociguat

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
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2023-03-17
Completion
2023-04-06

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 NCT06180096 on ClinicalTrials.gov