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Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: aripiprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.

Clinical Details

Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)

Secondary outcome: Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Body mass index (BMI) of 18 to 40 kg/m2

- Subjects with bipolar I disorder who are clinically stable on a stable dose of at

least 100 mg lamotrigine for at least 4 weeks prior to study entry

- Men and women, ages 18 to 65

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Patients with any significant acute or chronic medical illness, other than bipolar I

disorder

- Subjects with active psychotic symptoms

- History of head trauma within the past 2 years

- History of akathisia requiring treatment

- History of tardive dyskinesia or abnormal involuntary movements

- Subjects with a predisposition to orthostatic hypotension

- Positive urine screen for drugs of abuse

- Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4

weeks of study start

Locations and Contacts

Local Institution, Philadelphia, Pennsylvania, United States

Local Institution, Austin, Texas, United States

Local Institution, Bellaire, Texas, United States

Local Institution, Desota, Texas, United States

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2006
Last updated: November 7, 2013

Page last updated: August 23, 2015

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