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OpenTrials
Completed

NCT Number: NCT01443208

Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or female subjects
  • Between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion criteria

  • Elevated risk of suicide, in the opinion of the investigator or expert consultant
  • Pregnant or nursing females
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Treatment and study plan

Desvenlafaxine

Drug

one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Primary outcomes

  1. For single dose: maximum concentration (Cmax)

    Time frame: day 1

  2. For single dose: time to first occurence of Cmax (Tmax)

    Time frame: day 1

  3. For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)

    Time frame: day 1

  4. For multiple dose: maximum concentration (Cmax)

    Time frame: day 8

  5. For multiple dose: time to first occurence of Cmax (Tmax)

    Time frame: day 8

  6. For multiple dose: trough concentration (Ctrough)

    Time frame: day 8

  7. For multiple dose: area under curve (0-24hours) (AUC0-24)

    Time frame: day 8

Secondary outcomes

  1. For single dose if data permit: terminal elimination half life (t1/2)

    Time frame: day 1

  2. For single dose if data permit: area under curve (0-infinity) (AUCinf)

    Time frame: day 1

  3. For single dose if data permit: oral clearance (CL/F)

    Time frame: day 1

  4. For single dose if data permit: apparent volume of distribution (Vz/F)

    Time frame: day 1

  5. For multiple dose if data permit: accumulation factor (Rac)

    Time frame: day 8

  6. For multiple dose if data permit: terminal elimination half life (t1/2)

    Time frame: day 8

  7. For multiple dose if data permit: oral clearance (CL/F)

    Time frame: day 8

  8. For multiple dose if data permit: apparent volume of distribution (Vz/F)

    Time frame: day 8

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 29, 2011
Registry last updated
Jan 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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