Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule (CombiCapsIII)

University Hospital Basel

Status

Completed

Conditions

CYP450 Phenotyping

Treatments

Other: "Basel phenotyping cocktail" individual components

Other: "Basel phenotyping cocktail" capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03247699

2016-01766

Details and patient eligibility

About

Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.

Treatment in period A is the "Basel phenotyping cocktail" capsule. Treatment in period B consists of simultaneous intake of isolated formulations. In both study arms peripheral venous and capillary blood (DBS) samples will be drawn

Enrollment

12 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-50 years old
Caucasian male volunteers
Body mass index (BMI)18-30kg/m2,weight more than 50kg
Full mental and legal capacity
Signed informed consent prior to any study related procedure
Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol
Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm*, after 5min in the supine position at screening Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG)
Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening
No other conditions or circumstances that might interfere with compliance with study protocol

Exclusion criteria

Known hypersensitivity to any excipients of the drug formulations.
History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
History or presence of smoking (within the last 3months prior to screening) or alcohol or drug abuse
Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary supplements within 2weeks prior to the intended start of study.
Excessive caffeine consumption, defined as >800 mg per day at Screening Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450