Bioequivalence Study of Sitagliptin 100 mg Film-coated Tablets in Healthy Thai Volunteers

Phase 1

• Conditions: Healthy volunteer; Sitagliptin, Bioequivalence Study, Healthy Thai Volunteer

• Registration Number: TCTR20220317005
• Lead Sponsor: International Bio Service Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Study Completion: 2022-07-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Healthy Thai male or female subjects between the ages of 18 to 55 years, 2. Body mass index between 18.0 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

Exclusion Criteria

1. History serious hypersensitivity reactions, i.e., anaphylaxis, angioedema, exfoliative skin conditions including Stevens-Johnson syndrome, to sitagliptin, another dipeptidyl peptidase-4 (DPP-4) inhibitors or any other ingredient of the product, 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, diabetic ketoacidosis, 6. History or evidence of acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, 7. History or evidence of severe infection or serious accident within 14 days prior to check-in in each period, 8. istory or evidence of severe joint pain, 9. History or evidence of bullous pemphigoid, 10. History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer, 11. Have renal creatinine clearance (CrCl) < 45 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test, 12. History of sensitivity to heparin or heparin-induced thrombocytopenia, 13. History of problems with swallowing tablet or capsule, 14. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy, 15. History of diarrhea, dehydration or vomiting within 24 hours prior to check-in in each period, 16. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine), 17. 12-lead ECG demonstrating QTc > 450 msec, a QRS interval > 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 average of the three QTc or QRS values will be used to determine the subjects eligibility., 18. Investigation with blood sample shows positive test for HBsAg, 19. Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening, 20. Abnormal liver function, >= 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test, 21. 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, 22. 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.), 23. History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sitagliptin plasma concentrations 0.00-48.00 hours post-dose Cmax, AUC0-tlast and AUC0-inf

Secondary Outcome Measures

Name	Time	Method
Sitagliptin plasma concentrations 0.00-48.00 hours post-dose Tmax, t1/2, AUC0-tlast/AUC0-inf, AUC%extrapolate, Kel and MRT