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

NCT00975325 | Completed Phase 4

• 2 other identifiers: YOH-BE-2009EudraCT No.2009-013122-16
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Keywords

Bioequivalency

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameter AUC, Cmax

  Day 1

Study Arms (2)

Yohimbine, Yohimbine "Spiegel"

ACTIVE COMPARATOR

Drug: Yohimbine

Yohimbine Yocon-Glenwood

ACTIVE COMPARATOR

Drug: Yohimbine

Interventions

Yohimbine DRUG

yohimbine 5 mg, one tablet, single dose only

Yohimbine, Yohimbine "Spiegel"

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male
• Ethnic origin: Caucasian
• Age: 18 - 55 years, inclusive
• Body-mass index1 (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
• Good state of health
• Non-smoker or an ex-smoker for a least 1 month
• Written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study

You may not qualify if:

• Safety concerns:
• Existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
• Existing hepatic and/or renal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
• Existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
• History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• Pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
• Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
• Subjects with severe allergies or multiple drug allergies
• Systolic blood pressure \<100/\>140 mmHg
• Diastolic blood pressure \<60/\>90 mmHg
• Pulse rate \<45/\>110 bpm
• Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
• Positive anti-HIV-test, HBs-AG-test or anti-HCV-test
• History of glaucoma
• Lack of suitability for the trial 14. Subjects exhibiting extreme genetic polymorphism of CYP 2D6 - "Poor or Ultra-rapid metabolizer" 15. Acute or chronic diseases which could affect absorption or metabolism 16. History of or current drug or alcohol dependence 17. Regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day 18. Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient 19. Regular intake of caffeine containing food or beverages of ≥ 500 mg per day 20. Blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject 21. Participation in a clinical trial during the last two months prior to individual enrolment of the subject 22. Regular treatment with any systemically available medication (except continuous usual replacement therapy e.g. L-thyroxine) within two weeks prior to the first administration of the study medication 23. Intake of yohimbine for any reason (e.g. fat burning, weight reduction, muscle improvement, post operative care and/or any therapy for erectile dysfunctions) within two weeks prior to first administration of the study medication 24. Subjects, who report a frequent occurrence of migraine attacks

Sponsors & Collaborators

• Walter Ritter GmbH & Co: lead

Study Sites (1)

SocraTec R&D GmbH

Erfurt, D-99084, Germany

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Frank Donath, MD

  SocraTec R&D GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 11, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

DE (1)