A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
研究概览
简要总结
The goal of the study is to learn what happens to different forms of molnupiravir (MOV) medications in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare the amount of MOV in the healthy person's body over time when different forms of medications are given.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- •History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
- •Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV).
- •History of a major surgery.
研究组 & 干预措施
Molnupiravir Treatment A
Participants receive molnupiravir reference capsule.
干预措施: Molnupiravir (Drug)
Molnupiravir Treatment B
Participants receive molnupiravir Formulation 1.
干预措施: Molnupiravir (Drug)
Molnupiravir Treatment C
Participants receive molnupiravir Formulation 1 after a high-fat meal.
干预措施: Molnupiravir (Drug)
Molnupiravir Treatment D
Participants receive molnupiravir Formulation 2.
干预措施: Molnupiravir (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma will be determined.
Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma will be determined.
Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 12 hours postdose
AUC0-12 of NHC in plasma will be determined.
Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
Cmax of NHC in plasma will be determined.
Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma will be determined.
Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma will be determined.
Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B
时间窗: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma will be determined.
次要结局
- AUC0-inf of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- AUC0-last of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- AUC0-12 of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 12 hours postdose)
- Cmax of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- Tmax of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- t1/2 of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- CL/F of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- Vz/F of NHC in plasma: Treatment B versus Treatment C(Pre-dose, and at designated timepoints up to 72 hours postdose)
- AUC0-inf of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- AUC0-last of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- AUC0-12 of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 12 hours postdose)
- Cmax of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- Tmax of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- t1/2 of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- CL/F of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- Vz/F of NHC in plasma: Treatment D versus Treatment A(Pre-dose, and at designated timepoints up to 72 hours postdose)
- Number of participants who experience one or more adverse events (AEs)(Up to ~ 38 days)
- Number of participants who discontinue study intervention due to an AE(Up to ~ 38 days)