Bioequivalence, Type 2 Diabetes
Conditions
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.
Interventions
DRUGSitagliptin/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
Sponsors
Galenicum Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 48 hours | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC) 0-t | 48 hours | Evaluation of plasma concentration-time curve from zero to the time of the last measurable time point t |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs), abnormal clinical laboratory test results, physical examination findings and glycemia. | 1 week | 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. |
Countries
Canada
Outcome results
None listed