Aripiprazole and Effexor XR Drug Interaction Study
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Bristol-Myers Squibb 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: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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: June 11, 2008
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