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Aripiprazole and Effexor XR Drug Interaction Study

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: 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. (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Multiple dose PK parameters for venlafaxine+metabolite when administered alone and with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured

Secondary outcome: Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Local Institution, Miami, Florida, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2006
Last updated: November 7, 2013

Page last updated: August 23, 2015

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