NCT00549510CompletedPhase 1
A Non-randomized, Open-label, Single-dose, Crossover Study to Evaluate the Dose Proportionality of the Final Fixed Dose Combination Formulation of COREG CR™ and Lisinopril.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy SubjectsCrohn's DiseaseNCT01114607GlaxoSmithKline24
Completed
Phase 1
Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® PresentationAsthmaNCT02218723GlaxoSmithKline30
Completed
Phase 1
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release TabletHigh Risk Coronary Artery DiseaseNCT02963116AstraZeneca12
Active, not recruiting
Phase 1
MK-0616 Pharmacokinetic study in Japanese and non-JapaneseHypercholesteremiaJPRN-jRCT2031220322Tanaka Yoshiyuki14
Completed
Phase 1
A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and AllopurinolChronic Kidney DiseaseNCT04550234AstraZeneca25