Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
Phase 1
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00549510
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This will be an open-label, single-dose, non-randomized, five-period crossover study in healthy volunteers. The duration of the study will last up to eleven weeks from screening to follow-up. PK samples will be taken.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Assessment of dose proportionality by comparison of PK parameters across dosing range Blood sampling over up to a 120 hour period post dose in all dosing sessions
- Secondary Outcome Measures
Name Time Method Characterization of PK, safety and tolerability Safety and tolerability will be assessed by clinical data from spontaneous Adverse Event reporting, nurse/physician observations, vital sign assessment, ECGs, and clinical laboratory tests The pharmacokinetic parameters to be evaluated are the Tmax and t1/2 of carvedilol [R(+) and S(-)enantiomers] and Tmax and t1/2 of lisinopril
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Austin, Texas, United States