Phase 1
N=21
A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03467971 ↗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
| Outcome | Result | p-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
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.