Healthy
Conditions
Keywords
Healthy Subjects
Brief summary
The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.
Interventions
DRUGVenlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.
Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects, ages 18 to 45 (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. * Body Mass Index (BMI) of 18 to 33 kg/m2, inclusive.
Exclusion criteria
* Subjects with a decrease in SBP of \>=20 mm Hg and increase in HR of \>=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening. * Supine BP of 90/50 mm Hg or lower at screening * SBP \>=140 mm Hg or DBP \>=90 mm Hg at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple dose PK parameters for venlafaxine+metabolite when administered alone and with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs | — |
Countries
United States
Outcome results
None listed