Aripiprazole and Lexapro Drug Interaction Study

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00361790

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

25

Starts

2006-08-01

Expected to finish

2006-11-01

Last updated by the study team

2013-11-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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