Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers

NCT05124717 | Completed Phase 1

• 1 other identifier: FK/MTF/FD-500
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to assess the bioequivalence of these products based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as primary endpoints.

Conditions

Pharmacokinetics

Keywords

bioequivalence; pharmacokinetics; generic drugs; Metformin 500 mg Prolonged Release Tablets; Prolonged Release Tablets; oral dosage form; Metformin

Outcome Measures

Primary Outcomes (2)

• AUC(0-t)

  area under the plasma drug concentration versus time curve

  up to 36 hours post-administration

• Cmax

  maximum plasma concentration observed

  up to 36 hours post-administration

Secondary Outcomes (7)

• AUC(0-∞)

  up to 36 hours post-administration

• AUC(0-12h)

  from time zero to time 12 hours after dosing.

• AUC(12h-t)

  12 hours after dosing up to 36 hours post-administration

• AUC(0-24h)

  from time zero to time 24 hours after dosing.

• tmax

  up to 36 hours post-administration

Study Arms (2)

Treatment A

EXPERIMENTAL

Test Product Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine)

Drug: Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine)

Treatment B

ACTIVE COMPARATOR

Reference Product Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)

Drug: Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)

Interventions

Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine) DRUG

One tablet of the Test product was administered orally with 240 mL of water.

Also known as: Diaformin® SR 500mg tablets (JSC Farmak, Ukraine), Diabufor® XR 500mg tablets (JSC Farmak, Ukraine)

Treatment A

Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK) DRUG

One tablet of the Reference product was administered orallyn with 240 mL of water.

Also known as: Glucophage® XR 500 mg

Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and non-pregnant and no breast-feeding females (must have a negative pregnancy test result prior to dosing). Caucasian race.
• Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
• Body Mass Index (BMI) 18.5 to 30.0 kg/m2, inclusive and body weight between 50 kg and 100 kg(on the day of screening).
• Subject was available for the whole study and has provided his/her written informed consent.
• Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead electrocardiogram (ECG). Minor deviations outside the reference ranges were acceptable, if were deemed not clinically significant by the Investigator.
• Subjects in good health and with glucose between 3.3 mmol/L-5.5 mmol/l at screening, as determined by screening clinical laboratory evaluations. Minor deviations outside the reference ranges were acceptable, if were deemed not clinically significant by the Investigator.
• Acceptance of use of contraceptive measures during the whole study by both female and male subjects.

You may not qualify if:

• Known cardiovascular disease, history of hypotension.
• Factors in the subject's history that may predispose to ketoacidosis (including pancreatic insulin deficiency, history of pancreatitis, caloric restriction disoroders, restricted food intake, alcohol abuse)
• Gastrointestinal, renal or hepatic diseases and/or pathological findings present or in history, which might interfere with the drug pharmacokinetics.
• Previous liver disease or elevations in serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.0 upper limit of normal (ULN) at the screening (for women 0-0.52 µmol/L and for men 0-0.68 µmol/L).
• Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug's safety, tolerability, bioavailability and/or pharmacokinetics of the Investigational Medicinal Product (IMP).
• History of kidney disease and with impaired renal function.
• History of severe allergy or allergic reactions to the study IMP, its excipients or related drugs.
• Clinically significant illness within 28 days before the first dosing, including major surgery.
• Any significant clinical abnormality including Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV. (On screening)
• Positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
• Positive results of drugs of abuse in urine at screening and at check-in.
• Positive result of alcohol breath test at screening and at check-in.
• Positive result of urine cotinine test at screening.
• Serious mental disease and/or inability to cooperate with clinical team.
• Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic blood pressure (BP) and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Study Sites (1)

QUINTA-ANALYTICA s.r.o.

Prague, 10200, Czechia

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Vlad Udovytskyi

  Joint Stock Company "Farmak"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 18, 2021
• Study Start: June 25, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)