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

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


- 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


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


Erectile Dysfunction


Yohimbine, Yohimbine, Yohimbine


SocraTec R&D GmbH


Not yet recruiting


Walter Ritter GmbH & Co

Results (where available)

View Results


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

Clinical Trials [539 Associated Clinical Trials listed on BioPortfolio]

Effect of Yohimbine on Colon Transit

This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed at which food travels through the stomach, intestines and colon, and if yohimbine affects the ...

Effects of Yohimbine and Naltrexone on Sexual Function

The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine and naltrexone in treating men with erectile dysfunction (ED) (the inability to achieve or main...

Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Procedurally Virtual reality exposure therapy (VRET) is quite similar to models of extinction of conditioned fears. Recent advances in animal research have identified pharmacological agent...

Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

This study will determine if acamprosate, a drug approved to treat alcoholism, decreases alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP. Yohimbine...

Rapid Antidepressant Effects of Yohimbine in Major Depression

This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of depression within a matter of hours. Purpose: This study will examine whether the drug yohimb...

PubMed Articles [3019 Associated PubMed Articles listed on BioPortfolio]

Erectile dysfunction: they don't talk, we don't ask.

Erectile dysfunction is an under-reported complication of diabetes mellitus affecting over half of male patients [1]. Although many men with diabetes consider that erectile dysfunction has a negative ...

Dexmedetomidine reduces ventilator-induced lung injury (VILI) by inhibiting Toll-like receptor 4 (TLR4)/nuclear factor (NF)-κB signaling pathway.

Mechanical ventilation (MV) may lead to ventilator-induced lung injury (VILI). Previous research has shown that dexmedetomidine attenuates pulmonary inflammation caused by MV, but the underlying mech...

Chrysophyllum cainito (apple-star): a fruit with gastroprotective activity in experimental ulcer models.

The gastroprotective potential of the methanolic extracts from peels (MEPe), seeds (MESe) and pulp (MEPu) of Chrysophyllum cainito L. (Sapotaceae) fruits was evaluated in mice using ethanol/HCl- and i...

Simultaneous quantitative determination of bioactive terpene indole alkaloids in ethanolic extracts of Catharanthus roseus (L.) G. Don by ultra high performance liquid chromatography-tandem mass spectrometry.

A rapid, sensitive and reproducible method using ultra-high-performance liquid chromatography coupled with electrospray ionization hybrid triple quadrupole-linear ion trap mass spectrometry (UHPLC-ESI...

Repositioning of molsidomine for its efficacy in diabetes induced erectile dysfunction in rats: In silico, in vitro and in vivo approach.

Well known risk factors for diabetic erectile dysfunction include impaired nitric oxide synthesis and endothelial dysfunction. We proposed to evaluate the efficacy of nitric oxide donor, molsidomine i...

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.

More From BioPortfolio on "Bioequivalence Study Comparing Two Test Products With One Reference Product, All Containing 5 mg Yohimbine"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Searches Linking to this Trial