Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Single Dose Crossover Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Film-coated Tablets in Healthy Male and Female Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549570
• Other study ID #: GLU-P6-810
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: September 2022
• Source: Galenicum Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of metformin/sitagliptin after a single oral dose administration under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

The main Inclusion Criteria were:

• non- or ex-smokers

• body mass index (BMI) within 18.5 to 30.0 kg/m2, inclusively

• no clinically significant abnormality found in the 12-lead electrocardiogram (ECG) performed at study entry

• negative pregnancy test for female subjects

• healthy according to medical history, complete physical examination (including vital signs) and laboratory tests (general biochemistry, hematology and urinalysis)

Exclusion Criteria:

• Females who were pregnant or were lactating

• History of significant hypersensitivity to metformin, sitagliptin 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 conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects

• History of significant gastrointestinal, liver or kidney disease that may have affected drug bioavailability

• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

• History of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases

• Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >119 msec and QTc > 450 msec for males and QTc > 460 for females) on the screening ECG or other clinically significant ECG abnormalities

• 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 previous 28 days before day 1 of this study

• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study

• Any history of tuberculosis and/or prophylaxis for tuberculosis

• Positive screening of alcohol and/or drugs of abuse

• Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests

• Females who were pregnant according to a positive pregnancy test

• Volunteers who took metformin and/or sitagliptin in the previous 28 days before day 1 of this study

• Volunteers who took an Investigational Product (in another clinical trial) in the previous 28 days before day 1 of this study

• Volunteers who had already participated in this clinical study

• Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of this study

• Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study

Related Conditions & MeSH terms

• Bioequivalence
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet

Locations

Country	Name	City	State
Canada	Algorithme Pharma	Mount Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Galenicum Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	48 hours
Primary	Area under the plasma concentration versus time curve (AUC) 0-t	Evaluation of plasma concentration-time curve from zero to the time of the last measurable time point t	48 hours
Secondary	Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia.	Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 20.1 (Medrio database) and graded as mild, moderate, or severe.; The principal investigator or qualified designee determined the relationship of any AE to the investigational product.	1 week