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Bioequivalence Study Comparing Two Test Products With One Reference Product, All Containing 5 mg Yohimbine

2014-08-27 03:19:24 | BioPortfolio

Summary

- Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied

- Products, dosage, and route of administration:

- Test 1: Procomil 5 mg (Walter Ritter GmbH & Co. KG, Germany), sugar-coated tablet containing 5 mg yohimbine hydrochloride, oral administration

- Test 2: 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:

3 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

Description

Study objectives

Primary Objectives:

- Characterisation of relative bioavailability of Test 1 and Test 2 in comparison to Reference after single dose administration under fasting conditions

- Assessment of bioequivalence of Test 1 vs. Reference and Test 2 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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Erectile Dysfunction

Intervention

Yohimbine, Yohimbine, Yohimbine

Location

SocraTec R&D GmbH
Erfurt
Germany
D-99084

Status

Not yet recruiting

Source

Walter Ritter GmbH & Co

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:24-0400

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Medical and Biotech [MESH] Definitions

A plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of ERECTILE DYSFUNCTION. It is also alleged to be an aphrodisiac.

A plant genus of the family RUBIACEAE. Members produce YOHIMBINE.

A plant genus of the family APOCYNACEAE. Species of this genus contain YOHIMBINE.

A subclass of alpha-adrenergic receptors (RECEPTORS, ADRENERGIC, ALPHA). alpha-2 Adrenergic receptors can be pharmacologically discriminated, e.g., by their high affinity for the agonist clonidine and the antagonist yohimbine. They are found on pancreatic beta cells, platelets, and VASCULAR SMOOTH MUSCLE, as well as both pre- and postsynaptically in the central and peripheral nervous systems.

The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.

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