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Clinical Trial Details

Trial ID: L4315
Source ID: NCT01546558
Associated Drug: Metformin
Title: Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin|DRUG: Ranolazine
Outcome Measures: Primary: Maximum observed plasma concentration (Cmax) of metformin, 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10|Area under the plasma concentration vs time curve over the dosing interval, at steady state (AUCtau) of metformin, 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10 | Secondary: Number of participants with adverse events, From time of signed informed consent to time of follow-up phone call, an expected average of 5 weeks|Maximum observed plasma concentration (Cmax) of ranolazine and metabolites, 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10|Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites, 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2012-02
Completion Date: 2012-03
Results First Posted:
Last Update Posted: 2012-07-11
Locations: SeaView Research Inc., Miami, Florida, 33126, United States
URL: https://clinicaltrials.gov/show/NCT01546558