Bioequivalence Between Integrated E-TRANS (Fentanyl) System and Separated (Two-Part) E-TRANS (Fentanyl) System

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm that the two forms of the device the Integrated E-TRANS (fentanyl HCl) system and the Separated (Two-Part) E-TRANS (fentanyl HCl) System provide the equivalent blood levels of medication (fentanyl HCL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Body Mass Index (of 18.0 to 28.0 kg/m2 at screening

• Healthy based on medical history, physical examination, blood chemistry, blood count, urinalysis, and electrocardiogram

• Blood pressure between 90 to 139 mmHg systolic (inclusive) and 50 to 89 mmHg diastolic (inclusive) after sitting for 5 minutes

Exclusion Criteria:

• Evidence of clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities, psychiatric disorders or acute infection

• Patients with confirmed screening QTc interval >450 msec or a history of additional risk factors for torsades de pointes, or the use of other medications that are currently being taken that prolong the QT/QTc interval (measure of electric conduction in the heart by ECG test)

• Patients who have supine-to-standing blood pressure decrease of >20 mmHg systolic or >10 mmHg diastolic after standing for 3 minutes or have symptoms of lightheadedness, dizziness, or fainting upon standing