Erectile Dysfunction Clinical Trial
Official title:
Characterisation of Relative Bioavailability and Assessment of Bioequivalence of Two Generic Yohimbine Formulations in Comparison With a Marketed Reference Product - an Open, Randomised, Single Dose, 3-period Change-over Study
- 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
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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