Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- (AUC) Area Under the Curve 0-48 for T4
研究概览
简要总结
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, 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
Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine administration (e.g. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Tecnoquimicas modified its Levothyroxine tablets formulation in order to comply with new pharmacopeical specifications. It will then evaluate the impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test formulation) relative to the reference formulation from Merck (Reference formulation)
This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a single dose (4 x 150 mcg tablets = 600 mcg) of the test formulation of levothyroxine and reference formulation of levothyroxine separately in each treatment period. There will be two treatment sequences (AB, BA) and a 42 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 Levothyroxine
Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
干预措施: Drug Levothyroxine 150 mcg (Drug)
Reference formulation of Levothyroxine
Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2
干预措施: Drug Eutirox 150 mcg (Drug)
结局指标
主要结局
(AUC) Area Under the Curve 0-48 for T4
时间窗: From 0 to 48 hours
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
Cmax for T4
时间窗: From 0 to 48 hours
-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours
次要结局
- Cmax for T3(From 0 to 48 hours)
- Kel(From 0 to 48 hours)
- AUC 0-48 for T3(From 0 to 48 hours)
- Tmax(From 0 to 48 hours)
研究者
Mauricio Vargas
Biopharmaceutical Studies Director
Tecnoquimicas