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Phase 1 N=21 Randomized Other

A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants

Healthy

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin and Gliclazide — 4974.2507; 8556.7752; 21192.1682; 21815.4021 Nanogram*hour per milliliter (ng*h/mL)

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Metformin/Gliclazide Fixed Combination (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Merck KGaA, Darmstadt, Germany
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin and Gliclazide
4974.2507; 8556.7752; 21192.1682; 21815.4021
PRIMARY
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin and Gliclazide
4722.4546; 8298.5628; 20348.8381; 20997.1704
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of Metformin and Gliclazide
717.5017; 870.7288; 968.0305; 1013.9753
SECONDARY
Time to Reach Maximum Plasma Concentration (Tmax) of Metformin and Gliclazide
3.6698; 7.2389; 6.5254; 8.5238
SECONDARY
Elimination Half Life (t1/2) of Metformin and Gliclazide
6.2547; 7.4892; 16.6222; 17.1044
SECONDARY
Apparent Volume of Distribution (Vz/f) of Metformin and Gliclazide
2003389.9474; 1200933.2647; 35189.3864; 33813.7843
SECONDARY
Apparent Total Body Clearance (CL/f) of Metformin and Gliclazide From Plasma
226.79; 125.93; 1.63; 1.55
SECONDARY
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
8; 7; 0; 0

Summary

This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.

Eligibility Criteria

Inclusion Criteria

  • Ethnicity: Mexicans
  • Weight between 55 and 95 kilogram (kg)
  • Body mass index between 18 and 27 kilogram per meter square (kg/m^2)
  • Nonsmokers or participants who do not smoke more than 5 cigarettes or 1 pipe a day
  • Good physical and mental health based on the clinical history and physical examination
  • All results from blood chemistry, hematology, and urinalysis should be within normal ranges or without clinically significant deviations as per Principal Investigator's judgment
  • Hematology complete blood count [CBC]: hematocrit and hemoglobin must be above the lower limit; upper limit may range up to 15 percent (%)
  • Liver Function Test range as defined in the protocol
  • Electrocardiogram (12 leads) without clinically significant pathological signs
  • All women of childbearing potential must have negative tests for pregnancy at screening, and at day -1 for each treatment period and at end of trial (EOT)
  • Vital signs (blood pressure and pulse) in supine position within normal ranges or with clinically significant abnormalities as per the Principal Investigator's judgment
  • All women of childbearing potential who are not pregnant or breastfeeding and who are using a highly effective contraceptive method for at least one month before and following dosing
  • Negative result for alcohol breath test and urine test for drugs of abuse at screening and at each day -1 of the 2 treatment periods
  • Negative serology tests for human immunodeficiency virus (HIV1 and HIV2 antibodies), hepatitis A (HAV), hepatitis B (HBV), hepatitis C (HCV) and venereal disease research laboratory (VDRL) test screening
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria

  • Participants who have received any investigational drug within 21 days prior to the study start
  • Participants who have donated or lost 450 milliliter (mL) or more of blood within 21 days prior to the study start
  • Participants with history of cardiovascular, renal, liver, metabolic, gastrointestinal, neurological, endocrine, or hematopoietic (any type of anemia) diseases; mental disease, surgery or other organic abnormalities which might affect the study of the investigational drug pharmacokinetics
  • History of gastrointestinal tract surgery
  • Participants with history of hypersensitivity to the study drug and/or any formulation's ingredient; history of drug induced anaphylaxis
  • Participants who take any other drug 30 days before the study drug dose and for which at least seven elimination half-lives had not elapsed
  • Renal failure or renal impairment assessed by using the Cockcroft-Gault formula
  • Participant's disagreement or lack of capacity to communicate and cooperate with the Investigator, lack of legal capacity or limited legal capacity which prevent him/her from continuing in the study
  • Refusal of the high-fat diet which is necessary to assess the food effect. Considerable deviations to the diet's normal nutritional patterns
  • Participants who have smoked tobacco, having drunk alcohol, or xanthines containing beverages or food above 600 mg of caffeine a day those who have had grilled food within 24 h prior to the drug dosing
  • Intake of grapefruit, orange, cranberries or their juices within 14 days prior to the drug's dosing and throughout the study
  • Legal inability or limited legal capacity
  • Incarcerated participants
  • Participants who have been exposed to agents known as liver enzyme systems' inducers or inhibitors, or who have taken potentially toxic drugs within 30 days prior to the study
  • Other protocol defined exclusion criteria could apply
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03467971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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