Study Completed

Bioequivalence

Bayer Identifier:

14845

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial summary

Enrollment Goal

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

Status	Institution	Location
Completed	Osaka Pharmacology Clinical Research Hospital	Osaka, 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

Additional Information

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