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

Type 2 Diabetes Clinical Trial

Official title:

Single Dose Crossover Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Film-coated Tablets in Healthy Male and Female Volunteers / Fed State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549583
• Other study ID #: GLU-P6-327
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2018
• Est. completion date: April 25, 2018

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 determine the bioequivalence of two different formulations of sitagliptin/ metformin after a single oral dose administration under fed conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• 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 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

Related Conditions & MeSH terms

• Bioequivalence
• Type 2 Diabetes

Intervention

Drug:
• 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

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