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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00387777
• Date of registration: 12/10/2006
• Primary sponsor: Grünenthal GmbH
• Public title: Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
• Scientific title: Multiple Dose Bioequivalence Trial Comparing a New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch.
• Date of first enrolment: October 2006
• Target sample size: 24
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00387777
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Dr. Baumann-Noss, MD
• Affiliation: IKP Mannheim

Key inclusion & exclusion criteria

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-inhibitiors, 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 equuivalent.

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)



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Patch with centrally acting analgesic

Drug: Transtec(R) PRO (buprenorphine)

Secondary ID(s)

631766

N.A.

Source(s) of Monetary Support

Please refer to primary and secondary sponsors