Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations

NCT00388219 | Terminated Phase 1

• 1 other identifier: 964711
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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 single dose application

Conditions

Healthy

Keywords

Buprenorphine; Transdermal patch; Centrally acting analgesic; Plasma level; Healthy volunteers

Interventions

Transtec (R) PRO (buprenorphine) DRUG

Eligibility Criteria

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

You may qualify if:

• Male Cucasian 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

You may not qualify if:

• Resting pulse \<= 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)

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (2)

IKP

Mannheim, 68167, Germany

Location

Unknown Facility

Mannheim, Germany

Location

MeSH Terms

Interventions

prolyl-proline; Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic 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

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: October 1, 2006
• Study Completion: November 1, 2006
• Last Updated: July 6, 2007

Record last verified: 2007-07

Locations

DE (2)