Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)

NCT05798715 | Completed Phase 1

• 1 other identifier: GRC/1/21/1044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp \& Dohme, The Netherlands)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cmax

  to measure the maximal measured plasma concentration

  Up to 36 hours post dose in each treatment period

Secondary Outcomes (1)

• Tmax

  Up to 36 hours post dose in each treatment period

Study Arms (2)

T test

EXPERIMENTAL

1 tablet contains 1000 mg Metformin HCl \& 50 mg Sitagliptin orally administrated with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing

Drug: Gleptomet 50/1000(Metformin HCl & Sitagliptin)

R Reference

ACTIVE COMPARATOR

1 tablet contains 1000 mg Metformin HCl \& 50 mg Sitagliptin orally administrated with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing

Drug: Janumet 50/1000(Metformin HCl & Sitagliptin)

Interventions

Gleptomet 50/1000(Metformin HCl & Sitagliptin) DRUG

Test drug

Also known as: Janumet

T test

Janumet 50/1000(Metformin HCl & Sitagliptin) DRUG

Reference drug

Also known as: Janumet

R Reference

Eligibility Criteria

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

You may qualify if:

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Females should be on a suitable birth control method.
• Fully informed subjects that consented to participate in the study.

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects who meet any of the contraindications to the administration of Sitagliptin and/or Metformin HCl.
• Subjects who are going to get an injection of dye or contrast agents for an x-ray procedure.
• Subject does not agree not to consume any medication or food which may affect CYP3A4 enzyme at least one week prior to first study drug administration until donating the last sample of the study.
• Subjects that do not agree not to consume alcohol-containing beverages and foods for 1 week before dosing and throughout the period of sample collection.
• Heavy smokers.
• Female subjects who were pregnant or nursing.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
• Subject is on a special diet (for example subject is vegetarian).
• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
• Subject has a family history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 60 days, before first study drug administration.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Eva Pharma: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

  PMID: 11381568 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

• Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

  PMID: 2004861 BACKGROUND

MeSH Terms

Interventions

Sitagliptin Phosphate; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Metformin; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

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

Model Details: Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: November 29, 2022
• Primary Completion: December 13, 2022
• Study Completion: January 13, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)