Status:
COMPLETED
Relative Bioavailability and Food Effect Study
Lead Sponsor:
Bayer
Conditions:
Pharmacology, Clinical
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults. Secondary objective: To evaluate safety and tol...
Detailed Description
Clinical pharmacology
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01489488
Start Date
January 1 2012
End Date
May 1 2012
Last Update
July 1 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cologne, North Rhine-Westphalia, Germany, 51063