Bioequivalence Study of Sodium Divalproate Tablets 500 mg
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
详细描述
This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.
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
- Single (Participant)
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 and Women from 18 to 50 years old
- •Diagnosed as healthy after a clinical examination
- •BMI from 18 to 30 kg/m2
- •Not smoking for at least 3 months
- •To sign the informed consent
- •Not having participated in a similar study for at least 4 months
排除标准
- •Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
- •Hematologic disorders, specially anemia and polycythemia
- •Permanent or temporal pharmacological therapy, prescribed or not
- •Smoking for the last 3 months
- •Alcohol drinker more than once a week
- •Drug abuse
- •Drug hypersensitivity
- •Angioedema or anaphylaxis history
- •Pregnancy or breast-feeding
- •HIV o Hepatitis B diagnosed
- •Blood donor in the past 30 days
研究组 & 干预措施
Test Formulation of Valproic Acid
Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2
干预措施: Valproic Acid 500 MG (Drug)
Reference Formulation of Valproic Acid
Valcote tablets 500 mg Single dose administered in dosing period 1 or 2
干预措施: Valcote 500 mg (Drug)
结局指标
主要结局
Cmax
时间窗: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
(AUC) Area Under the Curve 0-48
时间窗: From 0 to 48 hours
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
次要结局
- Kel(From 0 to 48 hours)
- Tmax(From 0 to 48 hours)