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Relative Bioavailability and Food Effect Study | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT01489488

Relative Bioavailability and Food Effect Study

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...

Lead sponsor: Bayer•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Bayer

Clinical pharmacology

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 1, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment32

Start dateJan 2012

Last updatedJul 1, 2015

Condition

Pharmacology, Clinical

Locations shown

Cologne, North Rhine-Westphalia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2015Data synced to Clareo: June 27, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions