TCTR20170523005尚未招募1 期
A Bioequivalence Study of Two Formulations of 2 x 6.25-mg Carvedilol Tablets in Healthy Thai Volunteers under Fasting Condition
T.O. Chemicals (1979) Ltd.0 个研究点目标入组 64 人开始时间: 2017年5月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
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
- •(blood pressure (systolic blood pressure not lower than 90 or not over
- •140 mmHg, diastolic blood pressure not lower than 60 or not over 90
- •mmHg), body temperature, pulse rate, respiratory rate) and physical
- •examination or showing no clinically significant abnormalities in the
- •opinion of clinical investigator
- •3. Screening 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))
- •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 seronegative and anti-HCV negative.
- •7. Female subject must have serum β-HCG negative.
- •8. Female subject who is childbearing potential or male subject 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.
- •9. Female subject who is non-childbearing potential (hysterectomy, both
- •ovaries removed, surgically sterilized or postmenopausal (for at least
- •12 consecutive months of amenorrhea)).
- •10. 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 at period 1 and period 2.
- •11. Non-smokers (never smoked or no smoking within the previous 1
- •12. 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 2.
- •13. Subjects must have ended any medications at least 1 month prior to
- •study Day 1 and agree to continue their refraining throughout the
- •follow up period.
- •14. Subjects must refrain from drinking caffeine and alcohol for at least 72
- •hours prior to study Day 1 and agree to continue their refraining
- •throughout the last collection time-point of period 2.
- •15. Have the ability to understand the requirements of the study and must
- •voluntarily sign and date an informed consent, approved by an
- •Independent Ethic Committee (IEC)/Institutional Review Board (IRB),
- •prior to the initiation of any screening or study-specific procedures.
排除标准
- •1. Known hypersensitivity to carvedilol and its components
- •2. Past medical history of renal and hepatic insufficiency.
- •3. Subject has 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 of cardiovascular, gastrointestinal, central nervous
- •system disease, renal and hepatic impairment; history or presence of
- •clinically significant illness; or history of mental illness that may affect
- •compliance with study requirements.
- •4. Have history of drug abuse in the opinion of the investigator, as judged
- •by medical history) in the last 12 months.
- •5. Have positive urine drug abuse testing (methamphetamine (Meth),
- •morphine (Mor), tetrahydrocannabinol (THC), cocaine (Coc) and
- •methylenedioxy methamphetamine (MDMA)) at screening visit or
- •before dose administration at each period.
- •6. Alcohol abuse or excessive use (in the opinion of the investigator, as
- •judged by medical history) in the last 12 months.
- •7. Have positive alcohol breathing test at screening visit or before dose
- •administration at each period.
- •8. Female subject is pregnant or breast feeding.
- •9. Difficulties swallowing tablets whole
- •10. Difficulties fasting or consuming standard meals
- •11. 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.
- •12. Participation in any investigation drug study within 1 month.
研究者
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