Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Completed · Phase 4
Conditions studied: Major Depressive Disorder
In brief
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 body and the effect of the drug will also be evaluated.
Key facts
- Study ID
- NCT00952653
- Run by
- Pfizer
- People needed
- 28
- Starts
- 2010-06-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2011-08-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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