Aripiprazole and Effexor XR Drug Interaction Study

Overview

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.

Full Title of Study: “Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2006

Interventions

  • 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.
    • Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.

Arms, Groups and Cohorts

  • Other: 1

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Otsuka Pharmaceutical Development & Commercialization, Inc.
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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