A Randomized, Open-label, Single-dose, 3-period Crossover Study to Assess the Effect of Food on the Pharmacokinetics of the Final Fixed Dose Combination Formulation of COREG CR and Lisinopril in the Fed and Fasted State.

GlaxoSmithKline1 site in 1 country24 target enrollmentNovember 2007

ConditionsHypertension

DrugsCOREG CR and lisinopril (FDC)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension
Sponsor: GlaxoSmithKline
Enrollment: 24
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 72 hour period post dose in all dosing sessions

Secondary Outcomes

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