Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.

Phase 1

Completed

• Conditions: Hypertension

• Registration Number: NCT00557128
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a randomized, open-label, single-dose, period-balanced, three-period crossover study conducted in healthy subjects designed to evaluate whether the absorption of the FDC formulation is affected by the ingestion of a high fat meal or is altered when taken in a fasted state.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-24
• Study Start: 2007-11
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2010-10
• Disposition First Submitted: 2010-10-13
• Disposition First Submitted QC: 2010-10-13
• Last Update Submitted: 2010-10-13
• Disposition First Posted: 2010-10-15
• Last Update Posted: 2010-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The effect of food on PK after high fat and standard meal Blood sampling over a 72 hour period post dose in all dosing sessions	72 hour period post dose in all dosing sessions

Secondary Outcome Measures

Name	Time	Method
Food effect on PK over 72 hours after meals compared to fasting, safety and tolerability assessed by spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical labs over 3 session crossover	72 hours after meals
Other pertinent pharmacokinetic parameters of carvedilol and lisinopril, as data permit, such as Tmax and t1/2 of carvedilol and Tmax and t1/2 of lisinopril

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States