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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Walter Ritter GmbH & Co.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Walter Ritter GmbH & Co
ClinicalTrials.gov Identifier:
NCT00975325
First received: September 8, 2009
Last updated: September 10, 2009
Last verified: September 2009
  Purpose
  • 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


Condition Intervention Phase
Erectile Dysfunction
Drug: Yohimbine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Walter Ritter GmbH & Co:

Primary Outcome Measures:
  • Pharmacokinetic parameter AUC, Cmax [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Yohimbine, Procomil Drug: Yohimbine
yohimbine 5 mg, one tablet, single dose only
Active Comparator: Yohimbine, Yohimbine "Spiegel" Drug: Yohimbine
yohimbine 5 mg, one tablet, single dose only
Active Comparator: Yohimbine Yocon-Glenwood Drug: Yohimbine
yohimbine 5 mg, one tablet, single dose only

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Safety concerns:

    1. Existing cardiac or haematological diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
    2. 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
    3. Existing gastrointestinal diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
    4. History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
    5. Pathological ECG (12 standard leads) which might interfere with the safety of the active ingredient
    6. Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
    7. Subjects with severe allergies or multiple drug allergies
    8. Systolic blood pressure <100/>140 mmHg
    9. Diastolic blood pressure <60/>90 mmHg
    10. Pulse rate <45/>110 bpm
    11. Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
    12. Positive anti-HIV-test, HBs-AG-test or anti-HCV-test
    13. 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
  • Administrative reasons 25. Subjects suspected or known not to follow instructions 26. Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975325

Locations
Germany
SocraTec R&D GmbH Not yet recruiting
Erfurt, Germany, D-99084
Contact: Mandy Burkert    0049 61715857116    mandy.burkert@socratec-pharma.de   
Principal Investigator: Frank Donath, MD         
Sponsors and Collaborators
Walter Ritter GmbH & Co
Investigators
Principal Investigator: Frank Donath, MD SocraTec R&D GmbH
  More Information

No publications provided

Responsible Party: MD Frank Donath (Principal Investigator), SocraTec R&D GmbH (CRO)
ClinicalTrials.gov Identifier: NCT00975325     History of Changes
Other Study ID Numbers: YOH-BE-2009, EudraCT No.2009-013122-16
Study First Received: September 8, 2009
Last Updated: September 10, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Walter Ritter GmbH & Co:
Bioequivalency

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Yohimbine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014