Exploratory Bioavailability of Two Formulations of Gliclazide MR Tablets 120 mg (I.R.I.S.) in Healthy Volunteers Under Fed and Fasting Conditions.

Trial details

Who runs it

Institut De Recherches Internationales Servier IRIS

Trial code

EU 2023-507802-15-00

Record updated

2023. november 3.

Original description

1. To evaluate the pharmacokinetics in plasma and the relative bioavailability of Gliclazide MR 120 mg tablets (I.R.I.S.), developed as Test A and Test B with three different releasing rates (slow, medium, and fast release rate), and two Diamicron® MR 60 mg tablets (I.R.I.S.), after a single oral administration under fasting conditions. 2. To evaluate the pharmacokinetics in plasma and the relative bioavailability of Gliclazide MR 120 mg tablets (I.R.I.S.) developed as Test A and Test B with a medium releasing rate, and two Diamicron® MR 60 mg tablets (I.R.I.S.) under fed conditions.Read full original descriptionShow less

A Single-Dose, Randomized, Open-Label, Crossover, Exploratory Bioavailability Study in Healthy Volunteers of Two Formulations of Gliclazide MR Tablets 120 mg (I.R.I.S.) and Two Diamicron® MR Tablets 60 mg (I.R.I.S.) under Fasting and Fed Conditions and Oral Solution of 60 mg Gliclazide (I.R.I.S.) under Fasting Conditions.

1. To evaluate the pharmacokinetics in plasma and the relative bioavailability of Gliclazide MR 120 mg tablets (I.R.I.S.), developed as Test A and Test B with three different releasing rates (slow, medium, and fast release rate), and two Diamicron® MR 60 mg tablets (I.R.I.S.), after a single oral administration under fasting conditions. 2. To evaluate the pharmacokinetics in plasma and the relative bioavailability of Gliclazide MR 120 mg tablets (I.R.I.S.) developed as Test A and Test B with a medium releasing rate, and two Diamicron® MR 60 mg tablets (I.R.I.S.) under fed conditions.

Inclusion: Free written informed consent prior to any procedure required by the study; Negative serology for HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAg), Hepatitis B core antibody (anti-HBc), or Hepatitis C Virus (HCV) antibody; Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening); If woman, meets one of the following criteria: a) is of non-childbearing potential; b) is of childbearing potential and agrees to use an accepted non-hormonal or hormonal contraceptive method, since at least 4 weeks prior to admission to the first study period until 4 weeks after the last study drug administration; If man, infertile, vasectomized (i.e., who has received medical assessment of the surgical success) or willing to comply with the following contraception requirements from the first up to 4 weeks after the last study drug administration: a) Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject). b) Barrier method (preferably male condom) during heterosexual intercourse, when the female partner is of childbearing potential; If man, willingness to not donate sperm during the course of the study and until 3 months (90 days) after the last study drug administration; Willingness to accept and comply with all study procedures and restrictions and availability for the duration of the study; Male or female subject between 18 and 50 years, inclusive, at the time of signing the informed consent; Body weight ≥50 kg for male and ≥48 kg for female participants, and body mass index (BMI) within 18.5 to 30.0 kg/m2, inclusive; No clinically relevant diseases captured in medical history, as judged by the Investigator; No clinically relevant abnormalities on physical examination, as judged by the Investigator; No clinically relevant abnormalities on vital signs, as judged by the Investigator; No clinically relevant abnormalities on 12-lead ECG, as judged by the Investigator; No clinically relevant abnormalities on clinical laboratory tests (clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator).

Exclusion: Positive result in drugs-of-abuse, cotinine, or ethanol tests; Use of a depot injection or an implant of any drug (except contraceptives) within the previous 6 months; Use of corticosteroids within the previous 6 months; Maintenance therapy with any drug or regular use of medication in the last 30 days (except contraceptives); Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months; Participation in any clinical trial within the previous 2 months; Participation in more than 2 clinical trials within the previous 12 months; Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 3 months; Use of any prescription or non-prescription drugs in the prior 30 days, that in the opinion of an investigator would put into question the status of the participant as healthy or is deemed to interfere with the pharmacokinetics of study drug; Use of miconazole within the prior 30 days; Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week (Period 1) or during the washout (Periods 2, 3, 4 and 5); Consumption of any alcoholic product within the previous 24 hours; Positive result in drugs-of-abuse, cotinine, or ethanol tests; Had major surgery within the past 30 days prior to study drug administration or planning to have major surgery within 30 days after the last study drug administration; Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients; Any other condition that the Investigator considers to render the subject unsuitable for the study; Any recent disease or condition or treatment that, according to the investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug; Known severe hypersensitivity reaction to any other drug; Any other condition that the investigator considers to render the subject unsuitable for the study period; Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety; History of documented hypoglycemia; History of endocrine diseases; History of drug or alcohol abuse; Blood hemoglobin below 12.0 g/dL for females, and 13.2 g/dL for males; Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) above the upper limit of normal range; Estimated renal creatinine clearance (CLCr) below the lower limit of normal range based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2; Known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; Difficulty in fasting or any dietary restriction (such as lactose intolerance, vegan, vegetarian, low-fat, low sodium, etc.), that may interfere with the diet served during the study; History of glucose-6-phosphate dehydrogenase (G6PD) deficiency; Positive result in pregnancy test; Average daily xanthine consumption >5 units of caffeinated beverages; Difficulty in swallowing capsules or tablets; Venous status at forearm or dorsal hand making it difficult to insert a venous peripheral catheter; If woman, is lactating; Positive result in pregnancy test.

EU CTIS 2023-507802-15-00