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 escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.
Interventions
DRUGEscitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg
Tablets, Oral, Escitalopram: 10 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 in 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple dose PK parameters for Lexapro when administered alone and coadministered 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