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Trial record 1 of 1 for:    NCT00387777
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Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387777
Recruitment Status : Terminated
First Posted : October 13, 2006
Last Update Posted : January 11, 2016
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE October 12, 2006
First Posted Date  ICMJE October 13, 2006
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
Official Title  ICMJE Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.
Brief Summary The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application.
Detailed Description

Main: To demonstrate the bioequivalence of the new buprenorphine transdermal patch T2rev formulation containing 13 mg buprenorphine (Test) as compared to Transtec(R) PRO 70 µg/h patch transdermal patch containing 40 mg buprenorphine as reference after multiple patch application. Pharmacokinetic target parameters are AUCss,Tau and Css,max.

Further: To assess the safety, tolerability, skin tolerability and adhesiveness of the patch applications. To evaluate the following further Pharmacokinetic parameters: Css,min, Css,ave, PTF, Swing, tss,max, and t1/2,z

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Patch with centrally acting analgesic
  • Drug: Transtec(R) PRO (buprenorphine)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: October¬†12,¬†2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male Caucasian subjects, aged 18 - 55 years
  • BMI between 18 and 30 kg/m2 inclusive, with a lover limit of body weight of 50 kg
  • Subjects must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters
  • Subjects giving written informed consent to participate within this trial

Exclusion Criteria:

  • Resting pulse rate <= 45 or >= 100 beats/min
  • Resting blood pressure:systolic blood pressure <= 90 and >= 160 mmHg, diastolic blood pressure <= 40 and >= 100 mmHg
  • History or presence of orthostatic hypotension
  • Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies, HCV antibodies
  • Participation in another clinical trial in the last 30 days before starting this trial (i.e., first administration of IMP)
  • Positive drug of abuse screening
  • Diseases or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • Marked repolarisation abnormality (e.g., suspicious or definite congenital long QT syndrome with QT/QTc>500msec or prolonged QTc, i.e.>450msec) or co-medication that is known to influence cardiac repolarisation substantially
  • Bronchial asthma
  • Definite or suspected history of drug allergy or hypersensitivity
  • Subjects who have received any prescribed and non-prescribed systemic or topical medication like analgesics, NSAIDs (except standard dose of a NSAID once a week for the treatment of headache), hypnotics, sedatives, narcotics, neuroleptics or other medications that may lower the seizure threshold, MAO-inhibitors, serotonin-reuptake-inhibitors, tricyclic antidepressants, other centrally acting substances and substances which are known to interact with the drug metabolizing enzymes (e.g., inhibitors or inducers of CYP3A4 or CYP2D6) four weeks prior to the start of the trial (i.e, first administration of IMP). Each case has to be decided upon individually by the investigator after consultation with the sponsor
  • Evidence of alcohol or drug abuse
  • Not able to abstain from consumption of:
  • Caffeine containing beverages or food (tea, coffee, cola, chocolate, etc.)
  • Quinine containing beverages or food (bitter lemon, tonic water)
  • Grapefruit juice (sweet, sour)
  • Poppy seeds containing beverages or food
  • Blood loss (> 100 mL) due to e.g., blood donation within 3 months before starting this trial (i.e., first administration of IMP)
  • History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness)
  • Known or suspected of not being able to comply with the trial protocol
  • Not able to communicate meaningfully with the investigator and staff
  • Smoking of > 10 cigarettes/day or equivalent.

Trial specific exclusion criteria:

  • Subjects not able to abstain from strenuous exercise during the whole course of the trial
  • Abnormality (e. g. scar, tattoo) or unhealthy skin at application site according to examination by the investigator
  • Existing chronic skin disease or history of skin disease at the application site within the last 4 weeks
  • Presence of one of the contraindications as detailed in the current Summary of Product Characteristics (SmPC).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00387777
Other Study ID Numbers  ICMJE 631766
2006-003177-27 ( EudraCT Number )
HP5303/10 ( Other Identifier: Grünenthal GmbH )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Baumann-Noss, MD IKP Mannheim
PRS Account Grünenthal GmbH
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP