Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
NCT01443208
Last updated date
ABOUT THIS STUDY
To evaluate the pharmacokinetics and safety of single dose and multiple doses of
desvenlafaxine in Korean healthy subjects and compare to westerners.
FOR MORE INFORMATION
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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
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
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet | |||
| Official Title ICMJE | A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects | |||
| Brief Summary | To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | |||
| Condition ICMJE | Major Depressive Disorder | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| 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 | 36 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2011 | |||
| Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01443208 | |||
| Other Study ID Numbers ICMJE | B2061137 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||