Status:
COMPLETED
Aripiprazole and Effexor XR Drug Interaction Study
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 aripipra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00362271
Start Date
August 1 2006
End Date
September 1 2006
Last Update
November 8 2013
Active Locations (1)
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1
Local Institution
Miami, Florida, United States