Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr

PHASE1TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

October 31, 2006

Conditions
Healthy
Interventions
DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 1

blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow, while samples collected

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 2

tourniquet applied just below patch application site and above blood draw site, while samples collected

DRUG

Mylan Fentanyl Transdermal System 25 mcg/h + Clinical Procedure 3

tourniquet applied just above patch application site, while samples collected

DRUG

Duragesic 25 mcg/h + Clinical Procedure 1

blood pressure cuff inflated directly over the transdermal system to 60-100 mmHg for 1 minute to block venous blood flow

DRUG

Duragesic 25 mcg/h + Clinical Procedure 2

tourniquet applied just below patch application site and above blood draw site, while samples collected

DRUG

Duragesic 25 mcg/h + Clinical Procedure 3

tourniquet applied just above patch application site, while samples collected

Trial Locations (1)

26505

Kendle International Inc., Morgantown

Sponsors
All Listed Sponsors
lead

Mylan Pharmaceuticals Inc

INDUSTRY

NCT00648414 - Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr | Biotech Hunter | Biotech Hunter