Comparative Bioavailability Study of Metformin/Sitaglipti... | NCT05549570

NCT05549570

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference group	Experimental	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	Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Test group	Experimental	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	Drug: Sitagliptin/Metformin HCl 50/850 mg film-coated tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin/Metformin HCl 50/850 mg film-coated tablet	Drug	The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet	Reference group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	48 hours
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000068900	Sitagliptin Phosphate
D008687	Metformin

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds