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临床试验/TCTR20180920004
TCTR20180920004已完成1 期

A Bioequivalence study of single dose, two-way crossover design with two-period, two-treatment of Octreotide-SBS 100 mcg/mL subcutaneous injection relative to Sandostatin®

Siam Bioscience0 个研究点目标入组 28 人开始时间: 2018年9月20日最近更新:
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适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
28
研究概览入排标准研究者记录与标识符相似试验

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.Willingness to provide written informed consent prior to participate in the study.
  • •2.Healthy Thai subjects are between 18 to 55 years of age.
  • •3.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2.
  • •4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 10 mL of blood for monitoring subjects’ safety after the completion of the study.
  • •5.Negative urine pregnancy test for women and no breast-feeding.
  • •6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.

排除标准

  • •1.History or evidence of allergy or hypersensitivity to Octreotide or any related drugs or any of the excipients of this product.
  • •2.Subject with B.P. is Systolic B.P < 90, ≥140 mm/Hg, Diastolic B.P < 60, ≥90 mm/Hg or pulse rate > 100 beats per minute.
  • •3.Serum bilirubin greater than 1.5 times the upper limit of reference range
  • •4.Serum creatinine greater than 1.5 times the upper limit of reference range
  • •5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
  • •6.Positive of hepatitis B or C virus.
  • •7.12-lead EKG demonstrating QTc >450 msec, a QRSD >120 msec or with an abnormality considered clinically significant at Screening. 8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma or thyroid disease .
  • •9.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
  • •10.History of psychiatric disorder.
  • •11.History of regular alcohol consumption
  • •12.History of usually smoking
  • •13.High caffeine consumption
  • •14.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids).
  • •15.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication 16.History of difficulty in accessibility of veins in left and right arm.
  • •17.Blood donation (one unit or 450 mL) within the past 3 months before the study.
  • •18.Participation in any clinical study within the past 3 months before the study.
  • •19.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.

研究者

发起方
Siam Bioscience

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