NL-OMON49360已完成不适用
A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial - Glepaglutide BE study: subcutaneous and autoinjector administration
Zealand Pharma A/S0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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 至 99（—）
入选标准
- •1. Informed consent of the subject has to e obtained before any trial-related
- •activities are performed (trial-related activities are any procedures that
- •would not have been performed during normal management of the subject).
- •2. Subject has to be a healthy male or female aged between 18 years and 54
- •years, both inclusive, at screening.
- •3. Body mass index (BMI)of the subject has to be >20.0 kg/m2 and <29.9 kg/m2,
- •both inclusive, at screening.
- •4. Subject is willing to maintain a stable weight for the duration of the trial.
- •5. Subject is in overall good health according to age (medical history,
- •physical examination, vital signs, and laboratory assessments), as judged by
- •the Investigator at screening.
排除标准
- •1. Subject cannot have a significant medical history or clinical manifestation
- •of any metabolic, allergic, dermatological, hepatic, renal, hematological,
- •pulmonary, cardiovascular, gastrointestinal, neurological, respiratory,
- •endocrine, or psychiatric disorder, as determined by the Investigator.
- •2. Subject with a history of colon cancer or a history of other cancers within
- •the last 5 years.
- •3. The physical examination of the subject should not show clinically
- •significant abnormalities in the standard 12-lead ECG, or vital signs
- •measurements as determined by the Investigator.
- •4. Clinically significant abnormality in hematology, clinical chemistry, or
- •urinalysis as determined by the Investigator (congenital nonhemolytic
- •hyperbilirubinemia [eg, Gilbert*s syndrome] is acceptable).
- •5. Subject cannot have a history of significant hypersensitivity, intolerance,
- •suspected hypersensitivity to glepaglutide or related products, or allergy to
- •any drug compound, food, or other substance, unless approved by the
- •Investigator.
研究者
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