Aripiprazole and Lexapro Drug Interaction Study

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00361790
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of escitalopram in healthy subjects. The safety and tolerability of aripiprazole and escitalopram co-administration will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-08
• Study First Posted: 2006-08-09
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-06
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 in 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Multiple dose PK parameters for Lexapro when administered alone and coadministered 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; 🇺🇸 Lenexa, Kansas, United States