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Clinical Trial Details

Trial ID: L4614
Source ID: NCT03310749
Associated Drug: Gemigliptin
Title: An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Gemigliptin|DRUG: Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day|DRUG: Metformin
Outcome Measures: Primary: Gemigliptin AUCτ,ss Geometric Mean Ratio (and 90%CI), AUCτ,ss Geometric Mean Ratio for gemigliptin when administered concomitanty with metformin (test) to its administration alone (reference), At steady state, on the sixth planned treatment day | Secondary: Gemigliptin Cmax,ss Geometric Mean Ratio (and 90%CI), Cmax,ss Geometric Mean Ratio for gemigliptin when administered concomitanty with metformin (test) to its administration alone (reference), At steady state, on the sixth planned treatment day|Metformin AUCτ,ss Geometric Mean Ratio (and 90%CI), AUCτ,ss Geometric Mean Ratio for metformin when administered concomitanty with metformin (test) to its administration alone (reference), At steady state, on the sixth planned treatment day|Metformin Cmax,ss Geometric Mean Ratio (and 90%CI), Cmax,ss Geometric Mean Ratio for metformin when administered concomitanty with metformin (test) to its administration alone (reference), At steady state, on the sixth planned treatment day|Ctrough,ss, Lowest plasma concentration prior to the next dose administration at steady state, At steady state, on the sixth planned treatment day|Aeτ,ss, cumulative amount of drug excreted in the urine during a dosing interval, At steady state, on the sixth planned treatment day|CLss/F, Apparent drug clearance, At steady state, on the sixth planned treatment day|CLR,ss, Renal drug clearance, At steady state, on the sixth planned treatment day|MR, Metabolic ratio, At steady state, on the sixth planned treatment day|Tmax, Time to maximum plasma concentration at steady state, At steady state, on the sixth planned treatment day | Other: Incidence of treatment-emergent adverse events, Incidence of adverse events occuring during the exposure to the study medications, From the first pre-treatment admission date, trough the 39 days required for completion of the planned treatment/sampling and washout periods up to and including the post-study safety visit, conducted at study day 44
Sponsor/Collaborators: Sponsor: Stendhal Americas, S.A. | Collaborators: Universidad Nacional Autonoma de Mexico|LG Chem
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-01-15
Completion Date: 2016-05-03
Results First Posted:
Last Update Posted: 2017-10-16
Locations: Unidad de Farmacología Clínica de la Facultad de Medicina de la Universidad Nacional Autónoma de México, Nezahualcóyotl, Estado de México, 57740, Mexico
URL: https://clinicaltrials.gov/show/NCT03310749