Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Concentration-time profile in plasma
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
"Basel phenotyping cocktail" capsule
Intervention: "Basel phenotyping cocktail" capsule (Other)
"Basel phenotyping cocktail" individual components
Intervention: "Basel phenotyping cocktail" individual components (Other)
Outcomes
Primary Outcomes
Concentration-time profile in plasma
Time Frame: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
Concentration-time profile in capillary blood
Time Frame: -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Concentration-time Profile assessed in capillary blood over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios
Secondary Outcomes
No secondary outcomes reported