Bioequivalence Study Healthy Thai Volunteers Bioequivalence Study Healthy Thai Volunteers
Conditions
Interventions
Each tablet contains sitagliptin phosphate equivalent to sitagliptin 100 mg.,JANUVIA,
Reg. No. 1C 71/55 (N), manufactured by Merck Sharp &
Dohme Ltd., Cramlington, Northumberland, UK and imported
by MSD (Thailand) Ltd. Bangkok, Thailand, Each film-coated
tablet contains 128.5 mg of sitagliptin phosphate monohydrate,
which is equivalent t
Experimental Drug,Active Comparator Drug
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
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
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) inhibitor 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 first dose or second dose 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 History or evidence of severe joint pain 9 History or evidence of bullous pemphigoid 10 History or evidence of heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma sitagliptin concentrations 0-48.00 hours post-dose Cmax, AUC0-tlast and AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma sitagliptin concentrations 0-48.00 hours post-dose Tmax, t1/2, AUC0-tlast/AUC0-infinity, AUC%extrapolate, Apparent first-order terminal elimination rate constant and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed