Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers

NCT ID: NCT05549583

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2018-04-25

Brief Summary

The objective of this study was to determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.

Conditions

Bioequivalence; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Reference group

Thirty minutes after the start of the breakfast, a single dose of the Reference formulation was administered with approximately 240 mL of water at ambient temperature

Group Type: EXPERIMENTAL

Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Intervention Type: DRUG

The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Test group

Thirty minutes after the start of the breakfast, a single dose of the Test formulation was administered with approximately 240 mL of water at ambient temperature

Group Type: EXPERIMENTAL

Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Intervention Type: DRUG

The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Interventions

Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

The subjects randomly received single oral dose of Sitagliptin/metformin hydrochloride (HCl) 50/1000 mg film-coated tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• non- or ex-smokers
• body mass index within 18.5 kg/m2 to 30.0 kg/m2, inclusively
• no clinically significant abnormality found in the 12-lead electrocardiogram (ECG) performed at screening
• negative pregnancy test for female subjects
• healthy according to medical history, complete physical examination (including

Exclusion Criteria

• Females who were lactating at screening
• Females who were pregnant according to the pregnancy test at screening or prior to the first study drug administration
• History of significant hypersensitivity to sitagliptin, metformin or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Presence of out-of-range cardiac interval (PR <110 msec, PR >200 msec, QRS<60 msec, QRS >110 msec and QTc >440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator
• Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• Any clinically significant illness in the 28 days prior to the first study drug administration
• Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would have put into question the status of the volunteer as healthy
• Any history of tuberculosis or proven contact with tuberculosis
• Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
• Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG [B] [hepatitis B]) or Hepatitis C Virus (HCV [C]) tests
• Volunteers who had already been included in a previous group for this clinical study
• Volunteers who took sitagliptin and/or metformin in the 28 days prior to the first study drug administration
• Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration
• Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration
• Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galenicum Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Sicard

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

Algorithme Pharma

Mount Royal, Quebec, Canada

Countries

Canada

References

Schnaars Y, Gaikwad S, Gottwald-Hostalek U, Uhl W, Ribot O, Varanasi KVS, Rodriguez L, Torrejon J, Gomez L. Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin-Metformin Fixed-Dose Combination Compared with the Originator Products. Diabetes Ther. 2023 Feb;14(2):347-362. doi: 10.1007/s13300-022-01349-2. Epub 2022 Dec 16.

Reference Type: DERIVED

PMID: 36526947 (View on PubMed)

Other Identifiers

GLU-P6-327

Identifier Type: -

Identifier Source: org_study_id