TCTR20220401003尚未招募1 期
A Bioequivalence study of a randomization blinded, single dose, two- way crossover design with two-period, two-treatment and two-sequence of Sitagliptin tablets 100 mg relative to JANUVIA 100 mg in healthy Thai adult volunteers under fasting condition.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Age: 18-55 years, Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration
- •2. Sex:Males and/or non-pregnant, non-lactating females.
- •a. Weight: Each subject is required to have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2Smoking Status: Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix VII: Nicotine Equivalence Estimates) are permitted.
- •3. Adequate venous access in both arms for the collection of a number of blood samples during the study.
- •4. Able to understand and sign the written Informed Consent Form.
- •a.Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidances for the region of submission and country of conductance.
- •5. Willing to follow the protocol requirements and comply with protocol restrictions and allow investigators to draw approximately 7 mL of blood for monitoring subjects safety after the completion of the study.
- •6. All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication which will include :
- •a.a normal or non-clinically significant physical examination, including vital signs (blood pressure, pulse rate, respiratory rate and forehead-surface temperature)
- •b.within normal limits or non-clinically significant laboratory evaluation results
- •c.Normal or non-clinically significant 12-lead EKG
- •d.Negative Hepatitis B antigen test
- •e.Negative Hepatitis C antibody test
- •f.Negative HIV test
- •g.Negative urine drug screen including at a minimum Metamphetamines, benzodiazepines, cocaine, opioids and Marijuana (THC),
- •h.if tobacco/nicotine use is suspected, a urine cotinine test may be performed at the discretion of the Principal Investigator or responsible physician and if performed, must be negative,
- •i.if warranted, other tests and/or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
排除标准
- •1. Social Habits :
- •a.Consumption of any alcoholic beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
- •b.Consumption of any caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
- •c.Consumption of seville oranges grapefruit, grapefruit-like, or grapefruit containing products within 48 hours prior to the initial administration of the study medication and until the completion of each period of the study.
- •d.Any recent, significant change in dietary or abnormal diet within 48.0 hours prior to study check-in.
- •e.History of drug and/or alcohol abuse within one year of start of study.
- •f.Use of any nicotine containing product within the 7 days prior to the initiation of initial administration of study medication until the completion of the study.
- •2. Medications :
- •a.Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication.
- •b.A depot injection or implant of any drug within 3 months prior to initial administration of study medication.
- •c.Use of any medication, vitamin, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 14 days prior to the initial administration of study medication.
- •3. Diseases :
- •a.History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
- •b.History of tuberculosis.
- •c.History of difficulties in swallowing, or any gastrointestinal disease (i.e. cholecystectomy) or previous GI surgery other than appendectomy which could affect drug absorption. History of gastrointestinal obstruction, particularly paralytic ileus.
- •d.Acute illness at the time of either the pre-study medical evaluation or dosing period I.
- •4. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study.
- •5. Intolerance to venipuncture.
- •6. Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
- •7. Allergy or hypersensitivity to Sitagliptin, other related products, or any inactive ingredients.
- •8. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •9. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject participation in this study.
- •10. Subject with B.P. is Systolic B.P < 90, >,= 140 mm/Hg, Diastolic B.P < 60, >,= 90 mm/Hg or pulse rate > 100 beats per minute.
- •11. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)*.
- •12. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- •13. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- •14. 15.Participation in any clinical study within the past
研究者
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