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Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)

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ClinicalTrials.gov Identifier: NCT00469053
Recruitment Status : Terminated (The trail end was achived according to the definition in the trial protocol)
First Posted : May 4, 2007
Last Update Posted : November 16, 2007
Sponsor:
Information provided by:
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE April 18, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date November 16, 2007
Study Start Date  ICMJE May 2007
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 (Protocol ID: 855509)
Official Title  ICMJE Multiple Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch (Protocol ID: 855509)
Brief Summary The purpose of this study is to determine whether two different analgesic transdermal patch formulations lead to same plasma levels of active ingredient after multiple dose application.
Detailed Description

Main: To demonstrate the bioequivalence of the new transdermal patch versus the current transdermal patch (Reference) after multiple patch application. Pharmacokinetic target parameters are AUCss, 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: Buprenorphine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
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 lower 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 protocol
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 NCT00469053
Other Study ID Numbers  ICMJE 855509
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang Timmer, Dr. CRS Clinical Research Services Mannheim
PRS Account Grünenthal GmbH
Verification Date November 2007

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