A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets and Reference Product (Galvus Met) in Healthy Thai Volunteers under Fed Conditions
- Conditions
- Bioequivalence Study Healthy Thai Volunteers
- Registration Number
- TCTR20231103001
- Lead Sponsor
- International Bio Service Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 44
1.Healthy Thai male or female subjects between the ages of 18 to 55 years
2.Body mass index between 18.5 to 30.0 kg/m2
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
5.Female subjects abstain from either hormonal methods of contraception (including
oral or transdermal contraceptives, injectable progesterone, progestin subdermal
implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone
replacement therapy for at least 28 days prior to check-in in Period 1. Injectable
contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to
check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive
methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days
prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female
subjects of non-childbearing potential must meet at least one of the following criteria
prior to check-in in Period 1:
-Postmenopausal for at least 1 year or
-Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or
abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
7.Have voluntarily given written informed consent (signed and dated) by the subject
prior to participating in this study
1. History of allergic reaction or hypersensitivity to vildagliptin or metformin HCl or to
any of the excipients
2. History or evidence of clinically significant renal, hepatic, gastrointestinal,
hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3. Have high risk for coronavirus infection based on risk assessment questionnaire or
diagnosed as confirmed case of COVID-19
4. History about administration of COVID-19 vaccine within 30 days prior to check-in in
each Period.
5. History or evidence of type 1 diabetes mellitus or lactic ketoacidosis or diabetic
ketoacidosis
6. Have abnormality of glucose (FBS)
7. Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening
8. History or evidence of acute pancreatitis
9. History or evidence of bullous pemphigoid or exfoliative skin lesion
10.History or evidence of heart failure
11.History of sensitivity to heparin or heparin-induced thrombocytopenia
12.History of problems with swallowing tablet or capsule
13.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
gastritis or duodenal or gastric ulceration other than appendectomy
14.History of diarrhea or vomiting within 24 hours prior to check-in in each period
15.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
16.12-lead ECG demonstrating QTc is greater than 450 msec, a QRS interval is greater than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the averageof the three QTc or QRS values will be used to determine the subject s eligibility.
17.Have eGFR (CKD-EPI) <30 mL/min/1.73 m2 based on serum creatinine results, at the
screening laboratory test or during enrollment.
18.Abnormal liver function, s greater than or equal to 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
19.Investigation with blood sample shows positive test for HBsAg
20.History or evidence of habitual use of tobacco or nicotine containing products and
cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for
entire duration of the study
21.History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e.,
alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.)
22.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result
In case of alcohol breath test result represents the alcohol concentration range of 1
- 10 mg% BAC and the physician carefully considers that the value came from other
reasons, not from the alcohol drinking behavior of subjects, the tes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma sitagliptin concentrations 36 hrs Cmax, AUC0-tlast and AUC0-infinity will be determined from the plasma concentration data of analytes.
- Secondary Outcome Measures
Name Time Method Plasma sitagliptin concentrations 36 hrs Tmax, t1/2, lambda z, AUC0-tlast/AUC0-infinity, AUC%extrapolate and MRT will be determined from the plasma concentration data of analy