Relative Bioavailability and Food Effect Study
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01489488
First received: December 8, 2011
Last updated: April 7, 2013
Last verified: April 2013
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Purpose
Relative bioavailability study in order to investigate different liquid formulations in comparison to a standard tablet
| Condition | Intervention | Phase |
|---|---|---|
|
Biological Availability |
Drug: Riociguat (BAY63-2521) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Relative Bioavailability and Food Effect Study of Two Oral Liquid Formulations in Comparison to a 1mg Tablet of Riociguat to Characterize Its Pharmacokinetic Properties in Healthy Male and Female Adult Subjects in a Randomized, Open Label, 5 Fold Crossover Design |
Further study details as provided by Bayer:
Primary Outcome Measures:
- Plasma concentration versus time profile of BAY63-2521 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse event collection [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 32 |
| Study Start Date: | December 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Riociguat (BAY63-2521)
Single dose of 2.4 mg riociguat as paediatric high dose formulation (fasted)
|
| Experimental: Arm 2 |
Drug: Riociguat (BAY63-2521)
Single dose of 2.4 mg riociguat as paediatric high dose formulation (fed)
|
| Experimental: Arm 3 |
Drug: Riociguat (BAY63-2521)
Single dose of 0.3 mg riociguat as paediatric high dose formulation (fasted)
|
| Experimental: Arm 4 |
Drug: Riociguat (BAY63-2521)
Single dose of 0.15 mg riociguat as paediatric low dose formulation (fasted)
|
| Experimental: Arm 5 |
Drug: Riociguat (BAY63-2521)
Single dose of 1 mg riociguat tablet (fasted)
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female volunteers
- Age 18-45 years
- Body mass index (BMI) 18.0-29.9 kg/m²
- Systolic blood pressure (SBP) 110-145 mmHg
- No drugs 2 weeks before treatment
- Nonsmokers for at least 12 weeks
Exclusion Criteria:
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
- Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Relevant diseases within the last 4 weeks prior to the first study drug administration
- Regular use of medicines
- Regular use of therapeutic or recreational drugs
- Use of any medication within the 2 weeks preceding the study
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01489488 History of Changes |
| Other Study ID Numbers: | 14986, 2011-001893-24 |
| Study First Received: | December 8, 2011 |
| Last Updated: | April 7, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
Relative bioavailability study |
ClinicalTrials.gov processed this record on May 23, 2013