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Clinical Trial Details

Trial ID: L6904
Source ID: NCT01546597
Associated Drug: Metformin
Title: Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine
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, 10, 15 and 20|Time to reach 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, 10, 15 and 20|Area under the plasma concentration versus 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, 10, 15 and 20 | Secondary: Number of participants with adverse events, participants will be followed upon signing informed consent until the follow-up phone call, an expected average of 7 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 Days 15 and 20|Time to reach 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 Days 15 and 20|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 Days 15 and 20
Sponsor/Collaborators: Sponsor: Gilead Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
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: Cetero Research, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT01546597