Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - Capsules. Open, Crossover, Randomized, Single Dose, Three Treatments, Three Periods and Six Sequences With Meal (Breakfast) Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Maximum drug concentration (Cmax)
研究概览
简要总结
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Included in study will be male volunteers.
- •Ages between 18 and 45 years old.
- •BMI (Body Mass Index) between 20 to 26 kilogram/meter square (kg/m^2).
- •Anti-doping tests negative results.
- •Negative test results for Ac human immunodeficiency virus (HIV), HBsAg (hepatitis B surface antigen), and rapid plasma regain (RPR; syphilis test).
- •Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase (ALP), Lactic Dehydrogenase, Asparate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac HIV, HBsAg and RPR, must fall within an interval between minimum and maximum values in connection to said tests accepted values.
- •Normal Electrocardiogram (ECG) and Chest X-rays.
- •Complete the scale 'Columbia Suicide Severity Rating Scale' (C-SSRS), before and after each dosification period.
- •Obtain a grade of zero in the C-SSRS.
- •Signed the Informed Consent corresponding to the bioequivalence study.
- •In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant".
排除标准
- •Electrocardiographic Anomalies; radiological
- •Anti-doping tests positive results,
- •Positive results regarding RPR; HIV and HBsAg tests.
- •Personal or family history of allergy to medication in question.
- •Having any kind of allergy, since these persons are in higher risk of suffering from medication allergy.
- •Tobacco use.
- •Persons undergoing any medical treatment.
- •Existence of concurrent or intercurrent disease.
- •History psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia).
- •Existence of justified doubt regarding questionnaire answers truthfulness.
- •Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study.
- •Presence of clinically important gastrointestinal diseases or malabsorption history during the last year.
- •Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption.
- •Drugs or alcohol addiction history requiring treatment.
- •Refuse to take the scale 'C-SSRS, before and after each dosification period.
- •Obtain a grade greater than zero in the C-SSRS.
- •Do not sign the Informed Consent corresponding to the bioequivalence study.
- •Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.
结局指标
主要结局
Maximum drug concentration (Cmax)
时间窗: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time to maximum drug concentration (Tmax)
时间窗: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t)
时间窗: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Area under the plasma concentration-time curve from zero hours to infinite (AUC0-infinity)
时间窗: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
次要结局
未报告次要终点