Status:
COMPLETED
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Lead Sponsor:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the bo...
Eligibility Criteria
Inclusion
- Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 Ilbs).
Exclusion
- Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Presence or history of glaucoma or intraocular pressure.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
- Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. History of drug abuse within 1 year before study day 1.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00952653
Start Date
June 1 2010
End Date
August 1 2010
Last Update
August 15 2011
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511