Aripiprazole and Lexapro Drug Interaction Study

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Escitalopram 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00361790

CN138-463 ST

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

1

Other group

Treatment:

Drug: Escitalopram 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