TCTR20161031001已完成1 期
Randomized, Single-Dose, Two-Way Crossover, Open-Label Study to Evaluate Pharmacokinetics of Caliberi® Orodispersible Film 20 mg and Cialis® Tablet 20 mg in Healthy Male Thai Subjects under Fasting Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- Male
入选标准
- •1.Male must be 18-55 years of age, body mass index (BMI) = 18-25 kg/m2, inclusive, at the time of screening.
- •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, total cholesterol, triglyceride, creatinine phosphokinase (CPK), lactic dehydrogenase (LDH), lactic acid, sodium (Na+), potassium (K+), chloride (Cl-), biocarbonate (CO2) and liver function test (aspartate aminotransferase (AST)/alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total protein, albumin, total bilirubin and 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-hepatitis C antibody (Anti-HCV) negative
- •7.Non-smokers (never smoked or no smoking within the previous 2 years)
- •8.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 (Study Day 1). Subjects must agree to refrain from these items until the last collection time-point of period II.
- •9.Subjects must have ended any medications at least 30 days prior to Study Day 1 and agree to continue their refraining throughout the follow up period.
- •10.Subjects must refrain from drinking caffeine and alcohol for at least 72 hours and one month, respectively prior to Study Day 1 and agree to continue their refraining throughout the last collection time-point of period II.
- •11.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 tadalafil and its components
- •2.Past medical history of renal and hepatic insufficiency
- •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, urological system, respiratory system, renal and hepatic impairment; history or presence of clinically significant illness; 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 are receiving other treatment for erectile dysfunction.
- •7.Subjects who have a significant or acute infection such as influenza at the time of screening and/or admission or known inflammatory process including muscle inflammation such as myalgia at screening.
- •8.Subjects with allergic rhinitis and non allergic rhinitis
- •9.Subjects who lost vision of one eye due to non-arteritic anterior ischemic optic neuropathy (NAION).
- •10.Subjects with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease) or conditions which may predispose them to priapism (such as sickle cell anemia).
- •11.Have history of drug abuse in the last 12 months.
- •12.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)
- •13.Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
- •14.Subjects who have a positive alcohol breathing test at screening or admission (the day prior to first dosing).
- •15.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.
- •16.Participation in any investigation drug study within 2 months.
研究者
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