* Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied * Products, dosage, and route of administration: * Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration * Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administration * Duration of treatment: 2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting conditions separated by a wash-out period of at least one week i.e. 6 treatment free days between all administrations
Study objectives Primary Objectives: * Characterisation of relative bioavailability of Test 1 in comparison to Reference after single dose administration under fasting conditions * Assessment of bioequivalence of Test 1 vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximal concentration Cmax obtained for yohimbine Secondary Objective: * Descriptive characterisation of safety and tolerability of the investigational products in the study population * Descriptive characterisation of blood pressure and pulse rate around Cmax of the investigational products in the study population Analytical methodology: Yohimbine in plasma samples will be analysed by use of a validated HPLC-MS/MS; intended LLOQ for yohimbine is 0.5 ng/ml
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
42
SocraTec R&D GmbH
Erfurt, Germany
Pharmacokinetic parameter AUC, Cmax
Time frame: Day 1
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