Aripiprazole and Effexor XR Drug Interaction Study
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00362271
- 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 aripiprazole and venlafaxine co-administration will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs
Trial Locations
- Locations (1)
Local Institution
🇺🇸Miami, Florida, United States
Local Institution🇺🇸Miami, Florida, United States