Major Depressive Disorder Clinical Trial
Official title:
A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
Verified date | December 2011 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pfizer Investigational Site | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | For single dose: maximum concentration (Cmax) | day 1 | No | |
Primary | For single dose: time to first occurence of Cmax (Tmax) | day 1 | No | |
Primary | For single dose: area under curve (0-time for last quantifiable concentration) (AUClast) | day 1 | No | |
Primary | For multiple dose: maximum concentration (Cmax) | day 8 | No | |
Primary | For multiple dose: time to first occurence of Cmax (Tmax) | day 8 | No | |
Primary | For multiple dose: trough concentration (Ctrough) | day 8 | No | |
Primary | For multiple dose: area under curve (0-24hours) (AUC0-24) | day 8 | No | |
Secondary | For single dose if data permit: terminal elimination half life (t1/2) | day 1 | No | |
Secondary | For single dose if data permit: area under curve (0-infinity) (AUCinf) | day 1 | No | |
Secondary | For single dose if data permit: oral clearance (CL/F) | day 1 | No | |
Secondary | For single dose if data permit: apparent volume of distribution (Vz/F) | day 1 | No | |
Secondary | For multiple dose if data permit: accumulation factor (Rac) | day 8 | No | |
Secondary | For multiple dose if data permit: terminal elimination half life (t1/2) | day 8 | No | |
Secondary | For multiple dose if data permit: oral clearance (CL/F) | day 8 | No | |
Secondary | For multiple dose if data permit: apparent volume of distribution (Vz/F) | day 8 | No |
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