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

NCT00975325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-06-26

No results posted yet for this study

Summary

* 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

Conditions

Interventions

DRUG

Yohimbine

yohimbine 5 mg, one tablet, single dose only

DRUG

Yohimbine

yohimbine 5 mg, one tablet, single dose only

Sponsors & Collaborators

  • Walter Ritter GmbH & Co

    lead INDUSTRY

Principal Investigators

  • Frank Donath, MD · SocraTec R&D GmbH

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975325 on ClinicalTrials.gov