Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

NCT00952653

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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.

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Official Title  ICMJE 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
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 body and the effect of the drug will also be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: DVS SR
Interventions:
  • Drug: Desvenlafaxine Succinate Sustained Release
  • Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00952653
Other Study ID Numbers  ICMJE 3151A1-1205
B2061001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP