check_circleStudy Completed

Bioequivalence

To establish the bioequivalence between riociguat tablet 1.0 mg intended to be marketed (# 502) and riociguat tablet 1.0 mg used for clinical samples (#512) in Japanese healthy adult male subjects

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A
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Trial summary

Enrollment Goal
24
Trial Dates
September 2010 - November 2010
Phase
Phase 1
Could I Receive a placebo
N/A
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Osaka Pharmacology Clinical Research HospitalOsaka, 532-0003, Japan

Trial design

Bioequivalence study of two tablet formulations of riociguat (BAY 63-2521) – Randomized, non-blind, two-way crossover study to establish the bioequivalence between riociguat tablet (Development No. 502) 1.0 mg and riociguat tablet (Development No. 512) 1.0 mg in Japanese healthy adult male subjects
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
N/A