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

Sponsor

Grünenthal GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT00469053

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Buprenorphine	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multiple Dose Bioequivalence Trial Comparing a Down-Scaled New Analgesic Transdermal Patch Formulation to an Analgesic Reference Patch (Protocol ID: 855509)

Study Start Date :

May 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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