A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Sitagliptin 100 mg Film-coated Tablets (MEDIGLIPTIN 100 mg) and Reference Product (JANUVIA) in Healthy Thai Volunteers under Fasting Conditions

Phase 4

• Conditions: type 2 diabetes; Sitagliptin phosphate monohydrate; Type 2 diabetes; DPP-A inhibitor

• Registration Number: TCTR20211220005
• Lead Sponsor: The medicpharma co.,ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Healthy Thai male or female subjects between the ages of 18 to 55 years
Body mass index between 18.0 to 30.0 kg/m2
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.
Non-pregnant woman (negative pregnancy test) and not currently breast feeding
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
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
Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

Exclusion Criteria

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
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
Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period
History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis
History or evidence of acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis
History or evidence of severe infection or serious accident within 14 days prior to check-in in each period
History or evidence of severe joint pain
History or evidence of bullous pemphigoid
History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer
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
History of sensitivity to heparin or heparin-induced thrombocytopenia
History of problems with swallowing tablet or capsule
Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
History of diarrhea, dehydration or vomiting within 24 hours prior to check-in in each period
History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
12-lead ECG demonstrating QTc more than 450 msec, a QRS interval more than120 msec or with an abnormality considered clinically significant at screening.
Investigation with blood sample shows positive test for HBsAg
Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening
Abnormal liver function, more than or equal 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
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
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.)
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
History or evidence of habitual consume of tea, coffee, xanthine or caffeine containin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate and extent between test product and reference time 0.00 (pre-dose; 2x4 mL in duplicate tubes) and at 0.33, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00, 34.00 and 48.00 hours post-dose. Pharmacokinetic analysis

Secondary Outcome Measures

Name	Time	Method
Safety of test product and reference product Before period 1, Before period 2 and the end of study Observation and clinical laboratory test