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Completed

NCT Number: NCT00362271

Aripiprazole and Effexor XR Drug Interaction Study

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other names: Abilify

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 9, 2006
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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