Trials / Terminated
TerminatedNCT00648414
Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr
Investigational Study of the Effect of Clinical Procedures on Drug Delivery of the Fentanyl Transdermal System (25 µg/hr; Mylan) and Duragesic® (25 µg/hr; Janssen) in Healthy Volunteers
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Mylan Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2006-10-01
- First posted
- 2008-04-01
- Last updated
- 2024-04-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00648414. Inclusion in this directory is not an endorsement.