NCT00387777

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

First QC Date

October 12, 2006

Last Update Submit

January 8, 2016

Conditions

Healthy

Keywords

BuprenorphineTransdermal patchmultidoseCentrally acting analgesicPlasma levelHealthy volunteers

Interventions

Patch with centrally acting analgesicDRUG
Transtec(R) PRO (buprenorphine)DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKP

Mannheim, 68167, Germany

Location

MeSH Terms

Interventions

Transdermal Patchprolyl-prolineBuprenorphine

Intervention Hierarchy (Ancestors)

Equipment and SuppliesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Dr. Baumann-Noss, MD

    IKP Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

October 1, 2006

Study Completion

December 1, 2006

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

DE(1)