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 100 mg /1000 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 100 mg / 1000 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brazil in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Overview
- Phase
- Phase 1
- Intervention
- Sitagliptin/Metformin HCl 100/1000 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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult male and female subjects aged ≥ 18 and ≤ 55 years.
- •Subjects is a non-or ex-smoker.
- •With a weight ≥ 50.00 kg.
- •With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 27.0 kg/m
- •Found healthy according to the clinical laboratory results and physical examination
- •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.
- •Intrauterine device (IUD or intrauterine system (IUS).
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 100/1000 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 100/1000 mg extended release film-coated tablet
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: 48 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time Frame: 48 hours
Evaluation of Area Under Plasma Concentration-Time Curve from Time Zero to the Last Measurable Concentration
Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)
Time Frame: 48 hours
Area Under Plasma Concentration-Time Curve from Time 0 to Infinite
Secondary Outcomes
- Number of participants with adverse events (AEs)(1 week)