Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- AUC0-t of Rosiglitazone Maleate
研究概览
简要总结
The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.
详细描述
This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy volunteers received, in each period, the test or the reference formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin - Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets. Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith Kline Brasil Ltda) in the form of film coated tablets. The population is composed by 26 healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years. Their body mass index (BMI) varied between 18,5 and 25. There are no restrictions regarding the ethnic group. The relative bioavailability of the two formulations, after oral administration, will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Avandamet test product
Test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 miligrams (mg) + 1000 mg in Period 1, followed by a 7-day washout period during which no medication was administered, followed by reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 mg + 500 mg in Period 2
干预措施: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg (Drug)
Avandamet reference product
Reference product: Avandamet (Rosiglitazone Maleate + Metformin) 2 miligrams (mg) + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet (Rosiglitazone Maleate + Metformin) 4 mg + 1000 mg in Period 2
干预措施: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg (Drug)
结局指标
主要结局
AUC0-t of Rosiglitazone Maleate
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
Cmax of Rosiglitazone Maleate
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
AUC0-infinity of Rosiglitazone Maleate
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
AUC0-t of Metformin Hydrochloride
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
AUC0-infinity of Metformin Hydrochloride
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
Cmax of Metformin Hydrochloride
时间窗: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
次要结局
未报告次要终点