Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Pfizer

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Midazolam

Drug: Desvenlafaxine Succinate Sustained Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952653

3151A1-1205

B2061001

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.