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Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00952653
Pfizer
Completed
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

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Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
An Open-Label, Two-Period, Sequential Drug Interaction Study to Evaluate the Effect of Multiple Doses of Desvenlafaxine Succinate Sustained Release (DVS SR) on the Pharmacokinetics of Midazolam When Coadministered in Healthy Subjects
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Desvenlafaxine Succinate Sustained Release
    50 mg DVS SR tablet days 1-6, period 2 only.
  • Drug: Midazolam
    4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
Experimental: DVS SR
Interventions:
  • Drug: Desvenlafaxine Succinate Sustained Release
  • Drug: Midazolam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2010
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00952653
3151A1-1205
B2061001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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