TCTR20161029001尚未招募1 期
Randomized, Single-Dose, Two-Way Crossover, Open-LabelStudy to Evaluate Pharmacokinetics of Bucretis® Orodispersible Film1.0 mg and Baraclude® Tablet 1.0 mg in Healthy Thai Subjects underFasting Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
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. Male/Female must be 18-55 years of age, body mass index (BMI) =
- •18-25 kg/m2, inclusive.
- •2. Must be in good health as determined by medical history, vital signs
- •(systolic blood pressure not lower than 90 or not over 140 mmHg,
- •diastolic blood pressure not lower than 60 or not over 90 mmHg), and
- •physical examination
- •3. Screening electrocardiogram (ECG) without clinically significant
- •abnormalities
- •4. Screening visit Laboratory values of blood test including hematology
- •(complete blood count (CBC) with differential), fasting blood sugar
- •(FBS), blood urea nitrogen (BUN), creatinine (Cr) analysis and liver
- •function test (aspartate aminotransferase (AST)/ alanine
- •aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP),
- •gamma-glutamyltransferase (GGT)), total protein, albumin, creatinine
- •phosphokinase (CPK), lactic dehydrogenase (LDH), lactic acid, sodium
- •(Na+), potassium (K+), chloride (Cl-), biocarbonate (CO2) must be
- •within the normal range or showing no clinically significant
- •abnormalities in the opinion of clinical investigator.
- •5. Urinalysis results within normal limit or showing no clinically
- •significant abnormalities in the opinion of clinical investigator
- •6. Must have serum HbsAg and anti-hepatitis C antibody (anti-HCV)
- •7. Must have negative result of anti-HIV
- •8. Female subjects must have serum β-HCG negative.
- •9. Female subject who is childbearing potential agrees to use an
- •acceptable birth control method from visit 1 to the follow up 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 follow up visit. Hormonal
- •contraceptives are not acceptable.
- •10. Female subject who is non-childbearing potential (hysterectomy, both
- •ovaries removed, surgically sterilized or postmenopausal (for at least
- •12 consecutive months of amenorrhea)).
- •11. Female subjects must agree not to become pregnant for the entire
- •participation period and must have a negative result for a urine
- •pregnancy test performing prior to dosing.
- •12. Non-smokers (never smoked or no smoking within the previous 2
- •13. Refrain from using herbal medications, dietary supplements (e.g., St.
- •John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit
- •or grapefruit juice, or pomelo within 14 days before the first
- •administration of study drug (Day 1). Subjects must agree to refrain
- •from these items until the last collection time-point of period II.
- •14. Subjects must have ended any medications at least 30 days prior to
- •administration of study drug and must not have a depot injection or an
- •implant of any medications within 6 months prior to administration of
- •study drug and agree to continue their refraining throughout the follow
- •15. Subjects must refrain from drinking caffeine and alcohol for at least 72
- •hours and one month, respectively prior to administration of study drug
- •on Day 1 and agree to continue their refraining throughout the last
- •collection time-point of period II.
- •16. Have the ability to understand the requirements of the study and must
- 另有 2 项未显示
排除标准
- •1. Known hypersensitivity to entecavir and any other similar class of
- •drugs and to any of its components
- •2. Past medical history of, pulmonary, renal, hepatic, pancreas,
- •hematological, endocrine, immunologic, dermatologic,
- •musculoskeletal, neurological or psychiatric disease and asthma
- •3. Subject has clinically significant disorders or a history of any illness
- •that, in the opinion of the investigator, might confound the result of the
- •study or pose an additional risk in administering study drug to the
- •subject. This may include but is not limited to: a history of relevant
- •drug or food allergies; history or presence of cardiovascular,
- •gastrointestinal, central nervous system disease, renal and hepatic
- •impairment; history or presence of clinically significant illness,
- •respiratory system, urological disorder; or history of mental illness that
- •may affect compliance with study requirements.
- •4. Subjects with stomatitis and glossitis that may affect buccal absorption
- •of investigational drugs
- •5. Subjects with an unhealed wound after tooth extraction or a wound on
- •the tongue or oral mucosa
- •6. Subjects who have a significant infection such as influenza at the time
- •of screening and/or admission or known inflammatory process at
- •screening and subjects who have acute gastrointestinal symptoms at the
- •time of screening and/or admission (e.g. nausea, vomiting, diarrhea,
- •heartburn).
- •7. Have history of drug abuse in the last 12 months
- •8. Subjects who tested positive test result for drugs of abuse (opiate
- •(morphine), benzodiazepine, methamphetamines, barbiturate,
- •cannabinoid (tetrahydrocannabinol (THC)), cocaine and 3,4-
- •methylenedioxy- methamphetamine (MDMA)) at screening or
- •admission (the day prior to dosing)
- •9. Alcohol abuse or excessive use (in the opinion of the investigator, as
- •judged by medical history) in the last 12 months
- •10. Subjects who have a positive alcohol breathing test at screening or
- •admission (the day prior to first dosing).
- •11. Female subject is pregnant or breast feeding.
- •12. Difficulty in swallowing whole tablets and capsules
- •13. Difficulty in fasting or consuming standard meals
- •14. Donation or loss of whole blood:
- •a. ≥ 50 mL and ≤ 499 mL within 30 days prior to dosing
- •b. ≥ 500 mL within 56 days prior to dosing
- •15. Participation in any investigational drug study within 2 months
研究者
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