Bioequivalence Assessment Between Two Imeglimin Hydrochloride Film Coated Tablet Formulations

NCT07127094 | Completed Phase 1 DMC

• 1 other identifier: BE0125GLI500-ATC/01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, randomized, single-dose, two-sequence, two-period, crossover study to assess the bioequivalence of Imeglimin HCl in Glimcoza 500 mg film coated tablet (Test product) in comparison with Twymeeg® 500 mg tablet (Reference product) in healthy 31 subjects under fasting condition.

Conditions

Bioequivalence Study in Healthy Subjects

Keywords

Imeglimin hydrochloride; Bioequivalence; oral tablet; diabetes

Outcome Measures

Primary Outcomes (3)

• AUC(0-72)

  The area under the plasma concentration-time curve up to 72 hours

  From time zero up to 72 hours in each study period

• AUC(0-inf)

  The area under the plasma concentration-time curve up to infinity

  From time zero up to 72 hours in each study period

• Cmax

  Peak plasma concentration

  From time zero up to 72 hours in each study period

Secondary Outcomes (1)

• Tmax

  From time zero up to 72 hours in each study period

Study Arms (2)

Glimcoza 500 mg film coated tablet

ACTIVE COMPARATOR

Test Product

Drug: Test Product (Glimcoza)

Twymeeg® 500 mg tablet

ACTIVE COMPARATOR

Reference Product

Drug: Reference (R) Twymeeg®

Interventions

Test Product (Glimcoza) DRUG

Tablet formulation

Glimcoza 500 mg film coated tablet

Reference (R) Twymeeg® DRUG

Tablet formulation

Twymeeg® 500 mg tablet

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects aged between 18 and 55 years.
• Non-smokers or mild smokers with a maximum limit of 5 cigarettes/day.
• Normal physical examinations at screening visit.
• Having BMI ranged between 18.5-30 kg/m2.
• Ability to communicate adequately with the clinical staff.
• Ability and agreement to comply with the study requirements.
• Normal BP and HR measured under stabilized conditions. • The Blood pressure is considered normal if the SBP falls within 100 to 140 mmHg, and the DBP within 60 to 90 mmHg. • The heart rate normal range is from 60 to 100 bpm. • Respiratory rate normal range is from 12 to 16 breaths per minute. • Temperature normal range is from 36.5ºC to 37.5ºC.
• Normal laboratory results within normal range or with clinically non-significant deviation including: Complete Blood Count, Clinical Chemistry: Random blood sugar, blood urea, creatinine, sodium, potassium, total bilirubin, alanine amino transferase (ALT/GPT), aspartate amino transferase (AST/GOT), alkaline phosphatase, total protein in serum, Lipid profile, urinalysis.
• Negative Virology tests: HIV (HIV Ab), hepatitis B (HBsAg), hepatitis C (HCV IgG).
• Negative results for abused drug analysis in urine (Amphetamine (AMP), Barbiturate (BAR), Benzodiazepine (BZO), Cannabinoid (THC), Cocaine, Opiates (Morphine (MOP), Tramadol (TRA)).
• Understanding of the study and agreeing to give a written informed consent.
• Using an adequate contraception method during the study and for at least 30 days after the study (for potential subjects).

You may not qualify if:

• \. Subjects who have atopic constitution, asthma or known allergy for the API under investigation and/or any other ingredients of the investigational product. 2. Presence of clinical relevance of cardiovascular, neurological, musculoskeletal, hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease.
• \. Symptomatic or asymptomatic orthostatic hypotension at screening defined by a decrease of SBP more than 20 mmHg or DBP more than 10 mmHg occurs between sitting/supine to standing position. The subject will be excluded (if the drug under investigation has antihypertensive properties or documented to have orthostatic hypotension as a side effect).
• \. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or herniotomy.
• \. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated in any drug research within the last two months before the first day of drug administration.
• \. Subjects who used any prescribed systemic medication (including OTC medication) within 2 weeks (or six elimination half-lives of this medication, whichever is longer) before the initiation of the study (except for single doses of analgesics which have no drug interaction with study product).
• \. Use of any vitamins or herbal products within 3 days prior to the initial dose of the study medication.
• \. Subjects who have any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the drug.
• \. Subjects who consumed grapefruit or grapefruit juice during 48 hr prior to drug administration, during the study.
• \. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or positive alcohol test.
• \. History of difficulty of swallowing. 12. Intake of enzyme-inducing, organ toxic, long half-life drugs within 4 weeks before start of the study 13. Subjects who follow a special diet due to any reason, e.g., vegetarian. 14. Has a recent acute infection. 15. Pregnant females or female subjects who practice lactation or unprotected females with pregnancy potential

Sponsors & Collaborators

• Aya Mohammed Abdel Magid Abdel Hamid: lead
• Advanced Research Center (ARC): collaborator
• Atco Pharma for Pharmaceutical Industries: collaborator

Study Sites (1)

Advanced Research Center (ARC)

Cairo, Egypt

Location

Related Publications (1)

• Rezk MR, Badr KA, Hosny AAEH, AbdelMagid AM. Bioequivalence assessment of imeglimin hydrochloride tablet, a novel glimin-class antidiabetic agent. Naunyn Schmiedebergs Arch Pharmacol. 2025 Nov 26. doi: 10.1007/s00210-025-04780-x. Online ahead of print.

  PMID: 41291275 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kamal A. Badr, PhD

  Advanced Research Center (ARC)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Model Details: single center, open label, randomized, single-dose, 2-sequence, 2-period, crossover, bioequivalence trial conducted under fasting conditions with healthy participants

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: March 9, 2025
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)