NCT06861842进行中（未招募）4 期
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
Centro de Atencion e Investigacion Medica1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年6月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
详细描述
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition, following the design:
Open-label, crossover, randomized, single-dose design of 300 mg lithium carbonate immediate release tablets, with two treatments, two periods, two sequences in fasting condition, with a washout time of 14 days between each dose, participation as a subject in these studies implies a higher than minimal risk for the subjects.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Men or women between 18 and 50 years of age at the time of signing the informed consent form.
- •Women who are unable to conceive, who are not pregnant or breastfeeding (To be considered unable to conceive, they must be at least 1 year postmenopausal or surgically sterile). Table
- •Female participants of childbearing capacity must be using adequate contraception for the past 6 months and agree to continue using an adequate contraceptive method for 30 days after signing the consent form
- •Have been clinically diagnosed as healthy by the study physician.
- •Subjects with clinical laboratory results within normal ranges and/or fit by medical screening. (Table 2)
- •Subjects were non-smokers for the last 3 months at the time of screening.
- •Having signed the informed consent for the study.
- •Body mass index between 18-30 kg/m
- •Subject with complete contact information (cell phone and/or landline contact, address).
- •Subject who has a family member or guardian with a contact telephone number.
- •Subject with the availability of time to comply with the scheduled visits and activities.
- •Subject who is willing to comply with the prohibitions and restrictions specified in this protocol.
排除标准
- •- Subject diagnosed with renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological, psychiatric, compulsive depressive disorder.
- •Subjects with a diagnosis of hematological disorders, such as anemia and/or polycythemia.
- •Subjects with history of gastric surgeries.
- •Permanent or temporary use of any type of medication either on their own initiative or by medical prescription 2 days prior to the hospitalization phase of the study. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the beginning of the present study.
- •Smoking in the last 3 months, regardless of the number of cigarettes at the time of selection.
- •Drinking alcohol in excess of 16 g 15 days prior to selection as a subject, this amount being equivalent to 1 beer or 2 glasses of wine.
- •Positive test for the consumption of drugs of abuse or psychoactive substances at the time of selection (Table 2).
- •Known hypersensitivity to the active substance or excipients of the test product.
- •Medical history of angioedema or anaphylaxis.
- •Pregnant or lactating woman.
- •Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.
- •Having participated in clinical studies in the 4 months prior to the start of the present study.
- •Having donated blood or having reported blood loss greater than 500 mL in the previous 30 days.
研究组 & 干预措施
Period 1
Active Comparator
Theralite® 300 mg
干预措施: Theralite® (Drug)
Period 1
Active Comparator
Theralite® 300 mg
干预措施: Actilitio® (Drug)
Period 2
Active Comparator
Actilitio® 300 mg
干预措施: Theralite® (Drug)
Period 2
Active Comparator
Actilitio® 300 mg
干预措施: Actilitio® (Drug)
结局指标
主要结局
AUC
时间窗: 0 hours - 72 hours
concentration plasma under curve AUC
Cmax
时间窗: 0 hours - 6 hours
peak concentration plasma Cmax
次要结局
- Tmax(0 hours - 6 hours)
研究者
Humberto Reynales MD MSc PhD
Principal investigator
Centro de Atencion e Investigacion Medica
研究点 (1)
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