A randomized, double blind, 2-treatment, 2-period, single-dose, cross over, comparative study to evaluate pharmacokinetics, safety and tolerability of Stelis Teriparatide [rh-PTH (1-34)] [teriparatide, Stelis Biopharma Pvt. Ltd., India] with ForsteoRegistered Trademark (teriparatide, Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands) in healthy volunteers following subcutaneous administration of a single dose of 20 mcg Teriparatide

Stelis Biopharma Pvt. Ltd.0 个研究点目标入组 24 人开始时间: 2015年4月20日最近更新: 2020年1月13日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 24

研究概览研究设计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
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 45 Years（—）
性别: All

入选标准

•1. Male or non-pregnant female between the ages of 18-45 years.
•2. Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50 kg at screening.
•3. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
•4. Must be in general good health as determined by the Investigator based on comprehensive medical history, physical examination findings, vital sign measurements, and clinical laboratory tests, unless considered not clinically significant by the Investigator.
•5. Ability to understand the purpose and risks of the study, and provide signed and dated study specific informed consent prior to any study-specific procedures.
•6. Able and willing to participate in the study according to the protocol for the full length of expected term of follow-up

排除标准

•1. Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus [test for hepatitis C virus antibody (HCV Ab)] or hepatitis B virus [test for hepatitis B surface antigen (HBsAg)].
•2. History of severe allergic reactions to any drug or anaphylactic reactions.
•3. Known allergy to Teriparatide or any other components of the product (both Test & Reference products).
•4. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamos cell carcinomas of the skin that have been completely excised and are considered cured).
•5. Has undergone major surgery within the previous 12 months from screening visit or is planning to undergo a major surgery within 12 weeks of screening visit.
•6. Female subjects who are pregnant or have a positive pregnancy test result currently breastfeeding, or planning to become pregnant during the course of the study.
•7. Vaccinations within 4 weeks, prior to study medicine administration in period 1.
•8. Blood donation (Greater than equal to 500 mL) within 30 days prior to screening.
•9. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
•10. History of alcohol or substance abuse.
•11. Positive result for drugs of abuse on admission to the study center including amphetamines, barbiturates, cocaine, methadone, 3, 4 methylenedioxymethamphetamine (ecstasy), phencyclidine, tetrahydrocannabinol, and opiates.
•12. Use of any tobacco product more than 5 times within 30 days prior to screening.
•13. Positive testing for alcohol at check-in.
•14. Alcohol use within 72 hours prior to dosing of period 01. Subjects must be willing to restrict alcohol use throughout their participation in the study.
•15. Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine that are above the upper limit of normal, any values for platelets or hemoglobin that are below the lower limit of normal, or any out of normal range values for white blood cells, serum sodium, or serum potassium or as determined by the Investigator,
•16. Clinically significant abnormalities in 12-lead ECG.
•17. Any previous treatment with any parathormone/teriparatide product, including investigational use.
•18. Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer.
•19. Treatment with any medication prescribed within 30 days prior to Day 1 or longer if the medication has a long half-life, and over-the-counter (OTC) products including analgesics, herbal remedies, vitamin therapy within 14 days prior to Day 1 or longer if the medication has a long half-life, unless agreed as not clinically significant by the Investigator (vitamins, minerals, and nutrition supplements may be taken at the discretion of the Investigator). Exception: contraceptives.
•20. Inability to comply with study requirements.
•21. Other unspecified reasons that, in the opinion of the Investigator or sponsor, make the subject unsuitable for enrollment.

研究者

发起方

Stelis Biopharma Pvt. Ltd.

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