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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: desvenlafaxine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01443208

B2061137

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

50 mg

Experimental group

Treatment:

Drug: desvenlafaxine

Drug: desvenlafaxine

Drug: desvenlafaxine

100 mg

Experimental group

Treatment:

Drug: desvenlafaxine

Drug: desvenlafaxine

Drug: desvenlafaxine

200 mg

Experimental group

Treatment:

Drug: desvenlafaxine

Drug: desvenlafaxine

Drug: desvenlafaxine