A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
研究概览
简要总结
The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
- •Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
- •Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- •Are agreeable to receiving study treatment by injections under the skin
- •Are agreeable to following study contraception requirements
排除标准
- •Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Smoke more than the equivalent of 10 cigarettes per day
- •Is a known user of drugs of abuse
研究组 & 干预措施
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)
Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Tirzepatide (Drug)
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)
Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Single Dose Pen (Device)
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)
Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Multi-use Prefilled Pen (Device)
Sequence 2: Tirzepatide by MUPFP / SDP
Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Tirzepatide (Drug)
Sequence 2: Tirzepatide by MUPFP / SDP
Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Single Dose Pen (Device)
Sequence 2: Tirzepatide by MUPFP / SDP
Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
干预措施: Multi-use Prefilled Pen (Device)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
时间窗: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: Cmax of Tirzepatide
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide
时间窗: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: AUC(0-t) of Tirzepatide
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
时间窗: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: AUC(0-∞) of Tirzepatide
次要结局
未报告次要终点