NCT07281872
进行中（未招募）
1 期
A Single-Center, Randomized, Open-Label, Two-Period, Two-Sequence, Single-Dose, Crossover Bioequivalence Study of Methylconalamin Injection and Methylconalamin for Injection in Healthy Subjects Under Fasting Conditions
Wanbangde Pharmaceutical Group Co., LTD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月29日最近更新:
概览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Wanbangde Pharmaceutical Group Co., LTD
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
概览
简要总结
This study is a single-center, randomized, open-label, two-period, two-sequence, single-dose, crossover bioequivalence trial conducted under fasting conditions in healthy adult volunteers. Participants will be randomized into two sequences (A and B). Each participant will receive a single intramuscular dose of the test or reference formulation according to the assigned sequence, with an adequate washout period between dosing. The primary objective of the study is to evaluate the bioequivalence of the two formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects have been fully informed of the study purpose, nature, procedures, and potential adverse reactions, voluntarily agree to participate, and have signed the informed consent form prior to any study-related procedures.
- •Male or female subjects aged 18 years or older, with an appropriate gender distribution.
- •Body weight: females ≥ 45.0 kg, males ≥ 50.0 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive); BMI = weight (kg) / height² (m²).
- •Subjects are able to communicate effectively with the investigators and can understand and comply with all study requirements.
排除标准
- •Known allergy to methylconalamin injection, methylconalamin injection, or any component of the formulations, or history of hypersensitivity (e.g., rash, urticaria).
- •History of clinically significant diseases or any other medical or physiological condition that could interfere with study results, including but not limited to disorders of the hematologic, cardiovascular, digestive, urinary, respiratory, nervous, immune, or endocrine systems, malignancy, psychiatric disorders, or metabolic abnormalities.
- •History of significant bleeding tendency, coagulation disorders, systemic bleeding, neutropenia, or thrombocytopenia.
- •Vaccination with any vaccine or live attenuated vaccine within 1 month prior to dosing, or planned vaccination during the study.
- •Consumption within 48 hours prior to dosing of foods or beverages that may affect metabolism (e.g., grapefruit, pomelo, mango, orange), alcohol, purine-rich or caffeine-containing foods/beverages (e.g., coffee, strong tea, chocolate), or foods rich in vitamin B12 (e.g., animal liver such as pork, beef, chicken, and shellfish such as oysters or clams).
- •Daily excessive consumption of tea, coffee, and/or caffeine-containing beverages (≥8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.
- •Use of any drugs that affect liver enzyme activity within 30 days prior to first dose (e.g., enzyme inducers such as barbiturates, carbamazepine, phenytoin, dexamethasone; inhibitors such as SSRIs, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones).
- •Use of any medication (prescription, over-the-counter, herbal, vitamin, or dietary supplement) within 2 weeks prior to screening, except for topical medications or eye drops with local effects.
- •Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit ≈ 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or positive alcohol breath test, or inability to abstain from alcohol during the study.
- •Smoking ≥5 cigarettes/day within 3 months prior to screening, or inability to stop tobacco use during the study, or positive nicotine test.
研究组 & 干预措施
Group A
Experimental
干预措施: Methylconalamin Injection(WP205) (Drug)
Group A
Experimental
干预措施: Methylconalamin for Injection (Drug)
Group B
Active Comparator
干预措施: Methylconalamin Injection(WP205) (Drug)
Group B
Active Comparator
干预措施: Methylconalamin for Injection (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 0 to 24 hours after each single intramuscular dose
次要结局
未报告次要终点
研究者
研究点 (1)
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