JPRN-jRCT2071210138已完成1 期
To compare the Pharmacokinetics (PK) / Pharmacodynamics(PD)of a single subcutaneous (sc) injection (3.6 mg) of MYL-1401H and G-Lasta in Japanese healthy adult volunteers
Koichi Iwai0 个研究点目标入组 171 人开始时间: 2022年3月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
研究概览
简要总结
The study demonstrated bioequivalence between MYL-1401H and G-Lasta based on the primary PK and PD parameters. Additionally, both products had similar safety and tolerability profile after the single administration
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •A subject will be eligible at the screening visit (unless otherwise stated) if all of the Protocol apply
- •1 Willingness and ability to provide informed consent.
- •2 Japanese male and/or female
- •3 Age: 20-55 years, inclusive.
- •4 Weight: >45 kg.
- •In addition, follow the criteria of the clinical trial protocol
排除标准
- •A subject will be not be eligible at the screening visit (unless otherwise stated) if any of the Protocol apply
- •1 Unable to follow protocol instructions in the opinion of the PI/SI.
- •2 Any past or concurrent medical conditions that potentially increase the subjects risks or affect the evaluation of any study results. Examples of these include medical history with evidence of clinically relevant pathology (e.g., sickle cell disorders,spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as acute respiratory distress syndrome (ARDS), interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis) and history of relevant drug and/or food allergies.
研究者
相似试验
已完成
1 期
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial FormulationsHealthyNCT02156375Janssen Research & Development, LLC140
已完成
1 期
A Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsHealthyNCT03334448Eli Lilly and Company49
已完成
1 期
Phase I - Pharmacokinetic Comparability Study in Healthy Male VolunteersHealthyNCT02469987Mylan Inc.111
已完成
1 期
Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®HealthyNCT03659305R-Pharm80
已完成
1 期
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy ParticipantsDiabetes MellitusNCT01476345Eli Lilly and Company80