Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film… (NCT06124560) | 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 Fasting Conditions.
Mexico58 participantsStarted 2022-10-28
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 fasting conditions.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/m2.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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):
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 3.7.
. 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.