Aripiprazole and Effexor XR 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 venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.

Key facts

Study ID

NCT00362271

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

38

Starts

2006-08-01

Expected to finish

2006-09-01

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 is 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
• SBP >=140 mm Hg or DBP >=90 mm Hg at screening

Where it is running

• Local Institution — Miami, Florida, United States

Full record on ClinicalTrials.gov

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