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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01443208
• Date of registration: 23/09/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
• Scientific title: A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
• Date of first enrolment: November 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01443208
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: desvenlafaxine

Primary Outcome(s)

For multiple dose: area under curve (0-24hours) (AUC0-24) [Time Frame: day 8]

For single dose: maximum concentration (Cmax) [Time Frame: day 1]

For multiple dose: trough concentration (Ctrough) [Time Frame: day 8]

For multiple dose: maximum concentration (Cmax) [Time Frame: day 8]

For single dose: area under curve (0-time for last quantifiable concentration) (AUClast) [Time Frame: day 1]

For single dose: time to first occurence of Cmax (Tmax) [Time Frame: day 1]

For multiple dose: time to first occurence of Cmax (Tmax) [Time Frame: day 8]

Secondary Outcome(s)

For multiple dose if data permit: terminal elimination half life (t1/2) [Time Frame: day 8]

For single dose if data permit: area under curve (0-infinity) (AUCinf) [Time Frame: day 1]

For multiple dose if data permit: apparent volume of distribution (Vz/F) [Time Frame: day 8]

For multiple dose if data permit: oral clearance (CL/F) [Time Frame: day 8]

For multiple dose if data permit: accumulation factor (Rac) [Time Frame: day 8]

For single dose if data permit: apparent volume of distribution (Vz/F) [Time Frame: day 1]

For single dose if data permit: oral clearance (CL/F) [Time Frame: day 1]

For single dose if data permit: terminal elimination half life (t1/2) [Time Frame: day 1]

Secondary ID(s)

B2061137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors