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

Primary Purpose

Bioequivalence, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Sponsored by
Galenicum Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bioequivalence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Algorithme Pharma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reference group

Test group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
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

Secondary Outcome Measures

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.

Full Information

First Posted
September 16, 2022
Last Updated
September 20, 2022
Sponsor
Galenicum Health
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1. Study Identification

Unique Protocol Identification Number
NCT05549570
Brief Title
Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers
Official Title
Single Dose Crossover Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Film-coated Tablets in Healthy Male and Female Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galenicum Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bioequivalence, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reference group
Arm Type
Experimental
Arm Description
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
Arm Title
Test group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Intervention Description
The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Evaluation of Peak Plasma Concentration (Cmax)
Time Frame
48 hours
Title
Area under the plasma concentration versus time curve (AUC) 0-t
Description
Evaluation of plasma concentration-time curve from zero to the time of the last measurable time point t
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia.
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sicard
Organizational Affiliation
Algorithme Pharma Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algorithme Pharma
City
Mount Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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