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AzTrials

PharmacokineticsPhase 1NCT05125575

Fed Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

A Phase 1 study testing Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Glucophage® XR 1000 mg Prolonged Release Tablets in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fed conditions. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Glucophage® XR 1000 mg Prolonged Release Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteCzechia
Study dates
11 Jan 2019to 19 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 had 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 (electrocardiogram). Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator.
  • Subjects in good health, as determined by screening clinical laboratory evaluations. Minor deviations outside the reference ranges were acceptable, if deemed not clinically significant by the Investigator.
  • Acceptance of use of contraceptive measures during the whole study by both female and male subjects.

Who cannot join

  • Known cardiovascular disease, history of hypotension.
  • Factors in the subject's history that might 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.
  • Previous liver disease with elevations in serum transaminases.
  • Acute or chronic diseases and/or clinical finding which might 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.
Show all 22Show fewer
  • 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 screening urine drugs abuse test or/and alcohol breath test or urine cotinine test, and positive pregnancy test on 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 100-140 mmHg for systolic blood pressure (BP) and/or 60-100 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
  • Body ear temperature was out of the range of 35.7-37.6°C at screening.
  • Orthostatic hypotension during the screening procedure.
  • Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse.
  • Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing.
  • Use of any prescription medication for a period of 28 days before the first dosing.
  • Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment/or food supplements within 14 days before the first dosing.
  • Getting a tattoo, body piercing or any cosmetic treatment involving skin piercing within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
  • Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
  • Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at screening.
  • Less than 30 days between exit procedure in previous study and the first dosing in this study.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • QUINTA-ANALYTICA s.r.o.

    Prague, 10200

Other trials in Czechia

About this study

Official title: Open, Comparative, Randomized, Crossover, Single Dose Bioequivalence Study of Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) vs Glucophage® XR 1000 mg Prolonged Release Tablets in Healthy Subjects Under Fed Conditions.

This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fed conditions.

Read the detailed description

An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fed Conditions.

During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0 hours after IMP administration.

Being tested
Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine), Glucophage® XR 1000 mg Prolonged Release Tablets
Keywords
bioequivalence, pharmacokinetics, generic drugs, Metformin 1000 mg Prolonged Release Tablets, Metformin, Prolonged Release Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)Drug

    Also called Diaformin ® SR

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

  • Glucophage® XR 1000 mg Prolonged Release TabletsDrug

    Also called Glucophage® XR

    One tablet of the Reference (R) product was administered orally with 240 mL of water.

Study groups in NCT05125575
Study groupRoleWhat they receive
Treatment AExperimentalTest Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)
Receives: Drug: Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)
Treatment BActive comparatorReference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)
Receives: Drug: Glucophage® XR 1000 mg Prolonged Release Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    maximum plasma concentration observed (Cmax)

    Measured: up to 36 hours post-administration

  2. AUC0-t

    Area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration (AUC0-t)

    Measured: up to 36 hours post-administration

Secondary outcomes (5)

  1. AUC0-∞

    Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)

    Measured: up to 36 hours post-administration

  2. tmax

    The time of the maximum plasma concentration (tmax).

    Measured: up to 36 hours post-administration

  3. λz

    Apparent first-order elimination (λz)

    Measured: up to 36 hours post-administration

  4. t1/2

    the elimination or terminal half-life (t1/2)

    Measured: up to 36 hours post-administration

  5. AUCres

    Residual area AUCres = 100 (AUC0-∞ - AUC0-t) / AUC0-∞ [%]

    Measured: up to 36 hours post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2021
  2. Study start11 Jan 2019
  3. Primary completion19 Jan 2019
  4. Study completion19 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05125575
Sponsor's protocol ID
FK/MTF/FD
Status last verified
Nov 2021
First submitted
8 Nov 2021
Last updated
18 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Glucophage® XR 1000 mg Prolonged Release Tablets in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: up to 36 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05125575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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