Aripiprazole and Effexor XR Drug Interaction Study

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
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.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 7, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 9, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-462 ST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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