Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

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

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