CTRI/2020/03/024009Other1 期
A Randomized, Open-Label, Three-period, Three-Way, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single Oral Dose of Amitriptyline Hydrochloride Capsules, 25 mg in Healthy, Adult Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- Other
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
入选标准
- •1. Healthy, adult males and females aged 18 to 45 years, inclusive, at screening
- •2. Body mass index (BMI) greater than equal to 18 to less than equal to 32 kg/m2 and total body weight greater than 50 kg (110 lbs) at screening.
- •3. Subject is able and willing to provide written informed consent and to complete all study procedures
- •4. Females of childbearing potential must not be pregnant (as confirmed by a negative serum pregnancy test) or lactating.
- •5. Women of childbearing potential must agree to use contraception (barrier method) throughout the study.
- •6. Male subjects must agree to use an acceptable form of birth control to prevent pregnancy in the female partner and must agree not to donate the sperm throughout the duration of the study.
- •7. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator.
- •8. Subjects not having clinically significant history or signs of significant hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease.
- •9. Medically healthy based on the absence of clinically significant abnormal vital sign measurements, clinical laboratory test results (especially tests for renal and hepatic function) or ECG parameters (including sick sinus syndrome, second- or third- degree atrial ventricular block, cardiogenic shock and decompensated heart failure), as determined by the Investigator.
- •10. The subject must be willing and able to comply with study restrictions and able to remain at the clinic for the required duration during the study, and is willing to return to the clinic for the follow-up evaluation as specified in this protocol.
排除标准
- •1. History of allergic reaction or a severe adverse reaction to amitriptyline or any other antidepressants or related excipients
- •2. History of alcohol or substance abuse within the past 12 months (DSM-V definition of alcohol or substance abuse)
- •3. History of depression, seizure (including febrile seizure), syncope or loss of consciousness due to head trauma
- •4. History or risk of serotonin syndrome
- •5. History of acute myocardial infarction within 1 year from day of screening
- •6. History of seizures within 1 year from day of screening
- •7. History of benign prostate hypertrophy
- •8. History of angle-closure glaucoma
- •9. Subjects with hyperthyroidism or taking thyroid medication
- •10. History of suicidal ideation as assessed by subject medical history
- •11. Use of concomitant prescription or non-prescription drugs, dietary supplements, or herbal supplements within 14 days before check-in in Period 1
- •12. History of difficulty in swallowing.
- •13. Subjects who donated greater than equal to 500 mL of blood within 56 days prior to check-in in period 1 or greater than equal to 50 mL and less than equal to 499 mL of blood within 30 days prior to check-in in Period 1
- •14. Subjects who have had a tattoo or body piercing within 30 days prior to check-in in Period 1
- •15. ECG results indicating QTc greater than 450 msec (male) or greater than 470 msec (female) or QRS greater than 120 msec.
研究者
相似试验
进行中（未招募）
1 期
An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.ot applicable (submitted trial is a bioequivalence study in healthy subjects)MedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881CTIS2023-504760-42-00Dermax30
已完成
不适用
An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of Intravenous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjectsCTRI/2015/11/006383Serum Institute of India Ltd66
已完成
不适用
An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of subcutaneous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjectsCTRI/2015/04/005670Serum Institute of India Ltd48
进行中（未招募）
不适用
Study to determine bioavailablity of 300 mg aliskiren mini-tablets vs 300 mg aliskiren market tablet.MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersHypertensionEUCTR2012-000855-15-Outside-EU/EEAovartis Pharma Services AG69
尚未招募
1 期
A clinical trial to evaluate and compare the blood levels of aliskiren mini-tablets with aliskiren market tablet under fasted condition and futher evaluate aliskiren mini-tablets under fed condition in healthy subjectsCTRI/2009/091/000723ovartis Healthcare Private Limited69