TCTR20210824012尚未招募1 期
Bioequivalence study of sitagliptin 100 mg film-coated tablet in Thai healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
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 50 Years（—）
- 性别
- All
入选标准
- •1. Subjects who are Thai male and female, aged 18 to 50 years (inclusive).
- •2. Subjects whose BMI are 18.0-25.0 kg/m2.
- •3. Subjects who are healthy by medical history, physical examination, vital signs, electrocardiogram (ECG).
- •4. Subject whose screening visit laboratory tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin is within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator.
- •5. For female subjects:
- •Female subject who is in childbearing potential must have serum beta-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable.
- •Female subject who is in child bearing potential must agree not to become pregnant for the entire participation period and must have a negative result for urine pregnancy test performing prior to dosing at period I and II.
- •Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea).
- •6. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
排除标准
- •1. Subjects who are with a history/evidence of drug sensitivity or allergic reaction to sitagliptin, or any related drug.
- •2. Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects.
- •3. Subjects who regularly consume drinks with caffeine and/or grapefruit juice and cannot omit those drinks during the study at least 3 days prior to the study period 1 day 0 to the completion of the study period 2.
- •4. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least 14 days before the study period 1 day 0 and until the completion of the study period 2.
- •5. Subjects who are with a history of alcoholic (more than 2 years) or men who consumes more than 4 drinks on any single day and more than 14 drinks per week and cannot omit alcohol intake at least 7 days before the study and until the completion of the study period 2 or alcohol breath test is positive.
- •6. Subjects who are with a history of any positive test for drug abuse (morphine, methamphetamine and marijuana) on the enrollment day (strip test).
- •7. Subjects who receive of any medical prescription, herbal medicine and food supplement within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzymes.
- •8. Female subjects who are pregnant or breast feeding.
- •9. Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to the screening visit.
- •10. Subjects who are positive for COVID-19 test.
研究者
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