An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg / 500 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 50 mg / 500 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brasil in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Galenicum Health1 site in 1 country58 target enrollmentJanuary 13, 2023

ConditionsBioequivalence Diabetes Mellitus, Type 2

InterventionsSitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet

DrugsSitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet

Overview

Phase: Phase 1
Intervention: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
Conditions: Bioequivalence
Sponsor: Galenicum Health
Enrollment: 58
Locations: 1
Primary Endpoint: Peak Plasma Concentration (Cmax)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 sitagliptin/metformin extended release tablets after a single oral dose administration under fasting conditions.

Registry

clinicaltrials.gov

Start Date

January 13, 2023

End Date

February 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Galenicum Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult male and female subjects aged ≥ 18 and ≤ 55 years.
•Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before screening).
•With a weight ≥ 50.00 kg.
•With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 27.0 kg/m
•This BMI range covers both COFEPRIS (18.0 to 27.0 kg/m2) and GCC (18.5 to 30.0 kg/m2) requirements.
•Found healthy according to the clinical laboratory results and physical examination (performed within 28 days prior to the dosing on period 1).
•Have a normal 12-lead ECG and vital signs.
•Have laboratory test results within the laboratory's stated normal range; if not within this range, they must lack of clinical significance as judged by the PI or responsible physician.
•If the subject of the study is female and childbearing potential / fertile (a woman is considered fertile from first menstruation and until she becomes postmenopausal, or permanently sterile), and agrees to use ANY ONE of the following forms of effective contraception / birth control (but not limited to) from the time of enrollment into the study and until at least 7 days after the last study drug administration, as judged by the PI considering the pharmacology of IP(s):
•Established use of oral, transdermal, injected or subdermal implanted hormonal methods.

Exclusion Criteria

•Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any of its metabolites/derivatives or related drugs or excipients.
•Have a positive test result for HBs Ag or HCV Ab or HIV antibodies (types 1 and 2) or VDRL.
•The study drug is contraindicated for medical reasons for the subject as per protocol section 3.
•Have any history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, neurological or psychiatric disease or disorder (e.g., subjects with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute confusional states) as judged by the PI considering the pharmacology of IP(s).
•Presence of gastrointestinal, hepatic or kidney disease, or surgery or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
•Or Subjects with a history of gastrointestinal disorder or surgery which may affect the absorption of investigational drug.
•Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days prior to dosing of period
•Or Have history of vaccination (any dose) for COVID-19 during the last 14 days prior to dosing of period
•Or Any planned vaccination for COVID-19 during the study period.
•Have history or presence of cancer.

Arms & Interventions

Reference group

After an overnight fasting of at least 10.00 hours prior to dosing, subjects were administered a single-dose of the reference product along with 250 mL of 20% glucose in water solution at room temperature.

Intervention: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet

Test group

After an overnight fasting of at least 10.00 hours prior to dosing, subjects were administered a single-dose of the test product along with 250 mL of 20% glucose in water solution at room temperature.

Intervention: Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet