Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

November 7, 2005

Primary Completion Date

March 14, 2006

Study Completion Date

March 14, 2006

Conditions
Pain
Interventions
DRUG

Test Product T1: Buprenorphine patch (9 mg)

Buprenorphine transdermal patch formulation, containing 9 milligrams buprenorphine in an active surface area of 25 square centimeters.

DRUG

Test Product T2: Buprenorphine patch (3.8 mg)

Buprenorphine transdermal patch formulation, containing 3.8 milligrams buprenorphine in an active surface area of 10 square centimeters.

DRUG

Reference Product R: Transtec patch (20 mg)

Transtec (Registered Trademark) transdermal patch containing 20 milligrams buprenorphine in an active surface area of 25 square centimeters, release rate 35 micrograms per hour.

DRUG

Matching placebo patch to T1

Placebo patch to T1.

DRUG

Matching placebo patch to T2

Placebo patch to T2.

DRUG

Matching placebo patch to R

Placebo patch to R.

Trial Locations (1)

4123

Swiss Pharma Contract, Allschwil

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY