Status:
COMPLETED
Bioequivalence Between Integrated E-TRANS (Fentanyl) System and Separated (Two-Part) E-TRANS (Fentanyl) System
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
The objective of this study is to establish bioequivalence between the Integrated E-TRANS (fentanyl HCl) System and the Separated (Two-Part) E-TRANS (fentanyl HCl) System. The target indication is the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00990418
Start Date
March 1 2008
End Date
June 1 2008
Last Update
April 27 2010
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