Phase 1 Clinical Study To Describe the Biological Safety and Pharmacokinetics of Tyrphostin AG-17 Present in Oral Solid Formulations of the Fixed Dose Combination, in Three Different Concentrations of the Compound Tyrphostin AG-17 Content 10 mg, 3.3 mg and 1 mg Respectively, With 700 mg of L-Carnitine Tartrate Each Presentation, in a Single Dose in Healthy Research Subjects of Mexican Nationality
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Tolerance assessment
研究概览
简要总结
Evaluate the biological safety and pharmacokinetics of tyrphostin AG-17 present in the solid oral formulations of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17 contained 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality.
详细描述
Describe the tolerance of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17, containing 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in research subjects. healthy Mexican nationals, describing: type, frequency, duration, consequence, relationship with clinical history, management, follow-up; criteria: seriousness, severity; and classification of the AE or ADRs in accordance with the current NOM-220-SSA1 and estimate if there are differences by gender.
Assess the effects on body functions of the fixed dose combination, in three different concentrations of the compound tyrphostin AG-17 content 10 mg, 3.3 mg and 1 mg respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality through the measurement of physiological markers and estimate if there are differences by gender.
Obtain the biological blood samples necessary for the quantification of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg in accordance with Good Clinical Practices, always taking care to protect the vulnerability and integrity of the research subjects.
Quantifying the compound tyrphostin AG-17 with a previously validated bioanalytical method.
Estimate the pharmacokinetic parameters of the compound tyrphostin AG-17 at concentrations of 10 mg, 3.3 mg and 1 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator) The random assignment codes to the administration sequence will be under the protection of the Statistics Department. The Analytical Unit, the group of researchers from the Clinical Unit (medical staff) and the IS will remain blinded during the conduct of the study, the processing and analysis of the biological samples and in this way avoid biasing the results generated. Once the Clinical Phase is over, the opening code for the issuance of the Clinical Report and the Safety Report will be shared with the group of researchers of the Clinical Unit (medical staff).
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Research subjects aged: between 18 and 55 years.
- •Sex: 24 men and 24 women.
- •Weight: Research subjects with Body Mass Index between 18-27 kg/m
- •Research subjects with a diagnosis of "HEALTHY"; For this, a clinical history, medical examination, physical examination will be carried out in addition to taking samples to perform clinical analyzes (complete blood count with differential count, to evaluate hematological function, blood chemistry that evaluates pancreatic, renal, hepatic function, cardiac risk, metabolic function, biosafety tests, studies to rule out the presence of hepatitis B and C, HIV and VDRL, general urine test, fasting,). The results of the laboratory tests will be reviewed according to the reference values given by the laboratory and/or the reference values of Instruction I-DCL-VAL-030 "Range of normal values of laboratory tests", the tests The biosafety tests will have to have a NON-REACTIVE result and the cabinet studies (ECG) will have to have a NORMAL diagnosis granted by the Pharmometrica medical staff that evaluates them.
- •Research subjects with NEGATIVE results on qualitative drug of abuse tests, breathalyzer and rapid urine pregnancy test (for females), at the beginning of the study.
- •Based on the foregoing, the medical staff will determine whether the research subject has the physical capacity to participate in the study. Healthy will be understood as the research subject that meets all the inclusion criteria and does not meet any exclusion criteria.
- •Signature of the informed consent for participation in this study, by the IS.
排除标准
- •Research subjects with a medical history of allergies.
- •Research subjects who have ingested alcoholic beverages, tobacco or xanthines within 48 hours prior to the study.
- •Research subjects who have consumed grapefruit, grape, strawberry juice (generally red fruits such as blackberries or blueberries), spicy or charcoal-cooked foods 72 h prior to the study.
- •Research subjects who have participated in clinical research studies of any molecule, within 3 months prior to the study date.
- •Research subjects who were hospitalized for any reason or were seriously ill within 60 days prior to the study.
- •Research subjects who have donated or lost 450 mL or more of blood within 45 days prior to the study.
- •Research subjects with disease that require the use of medications Research subjects with medical history of cardiovascular, gastrointestinal, hepatic and/or renal insufficiency.
结局指标
主要结局
Tolerance assessment
时间窗: 30 days
* Description: type, frequency, duration, consequence, relationship with clinical history, management, follow-up * Criteria: severity (serious \[serious\] and non-serious), severity (mild, moderate and severe) * Classification: certain, likely, possible, unlikely, conditional/unclassified, not evaluable/unclassifiable
次要结局
未报告次要终点