Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DVS SR

Group Type EXPERIMENTAL

Desvenlafaxine Succinate Sustained Release

Intervention Type DRUG

50 mg DVS SR tablet days 1-6, period 2 only.

Midazolam

Intervention Type DRUG

4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.

Interventions

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Desvenlafaxine Succinate Sustained Release

50 mg DVS SR tablet days 1-6, period 2 only.

Intervention Type DRUG

Midazolam

4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes