NCT07565792招募中1 期
Study of Food Effects of VV913 Capsules in Chinese Healthy Volunteers
Vigonvita Life Sciences1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This study is a single-center, randomized, open label, 3×3 crossover design to assess the high-fat meal and the standard meal effects on PK of a single oral dose of VV913 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years old, males ;
- •Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m^2;
- •Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
- •Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
- •Participants who are able to understand and follow the study protocol and instructions; participants who have voluntarily decided to participate in this study, and sign the informed consent form.
排除标准
- •Participants with hypersensitivity to preparation or any of the excipients;
- •Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
- •Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);
- •Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
- •Participants with a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a history of blood product use within 3 months before screening;
- •Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
- •Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
- •Participants who have received vaccination within 14 days before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study;
- •Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, tetrahydrocannabinol, methamphetamine, dimethylene diphenazine , ketamine, and cocaine);
- •Participants who drink more than 14 standard units or at least twice a day per week within one year before screening (one standard unit equals 200 mL of beer with 5% alcohol or 25 mL of spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content);
- •Participants who smoke more than 5 cigarettes a day within one year before screening;
- •Participants who can't quit smoking or drinking during the trial period;
- •Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV）;
- •Having special requirements for food, unable to observe a unified diet or having dysphagia;
- •Participants who cannot avoid consuming drinks containing xanthine (such as coffee and tea) or foods (such as chocolate and animal liver), or fruits or juices (such as grapefruit, pomelo, mango, and dragon fruit) that may affect drug metabolism，from 48 hours before administration until the end of the study;
- •Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
- •Participants with difficulty in swallowing capsules;
- •Participants whose female partners plan to conceive within 3 months;
- •The investigator believes that there are other unsuitable factors to participate this trial.
研究组 & 干预措施
A group
Experimental
干预措施: VV913 (Drug)
B group
Experimental
干预措施: VV913 (Drug)
C group
Experimental
干预措施: VV913 (Drug)
结局指标
主要结局
AUC0-t
时间窗: 72 hours after dosing
area under the plasma concentration time curve from time zero to the last of VV913
Incidence of Adverse Events
时间窗: From dosing to follow-up call (4 days after last dose of VV913)
Incidence of Adverse Events
Cmax
时间窗: 72 hours after dosing
maximum observed plasma concentration of VV913
AUC0-∞
时间窗: 72 hours after dosing
area under the plasma concentration time curve from time zero to infinity of VV913
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Food Effect Study of VC005 Tablets in Healthy Adult Subjects.Atopic DermatitisNCT07533851Jiangsu vcare pharmaceutical technology co., LTD31
进行中（未招募）
1 期
评价健康受试者中食物对于 VV119 胶囊的药代动力学影响精神分裂症CTR20254481苏州旺山旺水生物医药股份有限公司
尚未招募
Unknown
A Phase IV, Clinical Study to Evaluate Safety and Efficacy of My V3 Ayurvedic Capsules in Healthy Participants.CTRI/2024/04/065842M/S. VEE HERBAL CARE PVT LTD32
进行中（未招募）
1 期
一项在健康成年受试者中开展的 VC005 片食物影响的临床试验特应性皮炎CTR20261242江苏威凯尔医药科技有限公司
Unknown
1 期
VCT220 片在中国健康受试者中单次给药剂量递增的安全性、耐受性和药代动力学特征以及食物对其药代动力学特征的影响的 Ia 期临床研究ChiCTR2500107810苏州闻泰医药科技有限公司