Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film… (NCT06124573) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
Mexico48 participantsStarted 2022-11-07
Plain-language 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 fed conditions.
Who can participate
Age range18 Years – 55 Years
SexALL
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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/m2.
✓. 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 ANYONE 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):
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.
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: 48 hours
2
Area under the plasma concentration versus time curve (AUC)0-t
Timeframe: 48 hours
3
Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)
✕. The study drug is contraindicated for medical reasons for the subject as per protocol section 3.7.
✕. 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.
✕. Have history or presence of Corona Virus Disease (COVID-19) during the last 30 days prior to dosing of period 1.
✕. Have history or presence of cancer.
✕. Have a history or evidence of drug abuse or alcohol abuse.