Aripiprazole and Effexor XR Drug Interaction Study

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Venlafaxine 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.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362271

CN138-462 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 venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine 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 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

Trial design

38 participants in 1 patient group

1

Other group

Treatment:

Drug: Venlafaxine 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.