Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers

NCT05124730 | Completed Phase 1

• 1 other identifier: FK/MTF/500/2021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to compare the bioavailability of the Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fasting conditions.

Conditions

Pharmacokinetics

Keywords

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

Outcome Measures

Primary Outcomes (2)

• AUC0-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 (8)

• AUC(0-∞)

  up to 36 hours post-administration

• AUC(0-12h)

  from time zero to time 12 hours after dosing.

• AUC(12h-t)

  from time 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

Metformin 500 mg Prolonged Release Tablets (JSC Farmak, Ukraine)

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

Treatment B

ACTIVE COMPARATOR

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

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

Also known as: Diaformin® SR (sustained-release) 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 Reference (R) Product was administered orally with 240 mL of water.

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 pregnansy 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 ECG. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator.
• All laboratory screening results within the normal range. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Clinical 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 disorders, 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.
• Glucose level out of the limit 3.3 mmol/L - 5.5 mmol/Lat screening, as determined by screening clinical laboratory evaluations.
• Previous liver disease or clinically significant elevations in serum transaminases at the screening.
• 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 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 and at check-in.
• Serious mental disease and/or inability to cooperate with clinical team.

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
• Masking Details: The study was open-labelled; however, analysts did not have access to the randomization scheme to prevent bias during analyses.
• 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: May 21, 2021
• Primary Completion: May 29, 2021
• Study Completion: May 29, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)