A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00280358
• Lead Sponsor: Dey

Brief Summary

The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.

Detailed Description

Not available

Study Timeline

• Study Completion: 2005-12
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-05
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Non-smokers, BMI 18-29, no current medications

Exclusion Criteria

• Significant conditions or disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Levels of study medication in blood and urine.

Secondary Outcome Measures

Name	Time	Method
Safety/tolerability

Trial Locations

Locations (1)

Research Site; 🇺🇸 Lenexa, Kansas, United States