Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under concentration-time curve (AUC)of perindopril parent compound
研究概览
简要总结
The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).
详细描述
The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier).
Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration.
Three weeks after the first drug administration (washout period), the procedure was repeated using the alternate drug.
The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).
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 (Investigator)
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
- •Healthy male and female subjects
- •Aged 18-55 years inclusive
- •A body mass index in the range of 18-25 kg/m2
- •Able to participate, communicate well with the investigators and willing to give informed consent
- •Non-smokers
- •Vital signs (after 10 minutes resting) are within the following ranges:
- •systolic blood pressure 100-125 mmHg
- •diastolic blood pressure 60-80 mmHg
- •pulse rate 60-90 bpm
排除标准
- •Pregnant or lactating women
- •Known hypersensitivity or contraindication to perindopril
- •Intake of any prescription drug within 14 days of this study's first dosing day
- •Intake of any non-prescription drug, food supplement, or herbal medicine within 7 days of this study's first dosing day
- •History or presence of any liver dysfunction (ALT, alkaline phosphatase, total bilirubin ≥ 1.5 ULN)
- •History of any bleeding or coagulation disorders
- •Clinically significant ECG abnormalities
- •Clinically significant haematology abnormalities
- •Renal insufficiency (plasma creatinine concentration ≥ 1.4 mg/dL)
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
- •A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
- •A positive hepatitis B surface antigen (HBsAg), anti-HCV, and anti-HIV
- •History of drug or alcohol abuse within 12 months prior to screening of this study
- •Participation in a previous study within 3 months of this study's first dosing day
研究组 & 干预措施
Perindopril 4 mg tablets of PT Dexa Medica
Group I (Test product): each tablet contains perindopril tert-butylamine salt 4 mg.
A single dose of perindopril tablet of PT Dexa Medica was given to each of study subjects.
干预措施: Perindopril 4 mg tablets of PT Dexa Medica (Drug)
Perindopril 4 mg tablets of Servier
Group II (Reference product) : each tablet contains perindopril tert-butylamine salt 4 mg.
A single dose of perindopril (Prexum) tablets of Servier was given to each of study subjects.
干预措施: Perindopril 4 mg tablets of Servier (Drug)
结局指标
主要结局
Area under concentration-time curve (AUC)of perindopril parent compound
时间窗: 192 hours
Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of perindopril parent compound.
Area under concentration-time curve (AUC)of perindoprilat
时间窗: 192 hours
Relative bioavailability (primarily measured by AUCt and AUCinf) between two perindopril 4 mg tablet formulations (test and reference formulations) under fasting condition. The AUC was measured based on the plasma concentration of the active metabolite, perindoprilat.
次要结局
- Peak plasma concentration (Cmax)of perindopril parent compound(192 hours)
- Peak plasma concentration (Cmax)of perindoprilat(192 hours)
- Time to achieve the peak plasma concentration (tmax)of perindopril parent compound(192 hours)
- Time to achieve the peak plasma concentration (tmax)of perindoprilat(192 hours)
- Elimination half-life (t1/2)of perindoprilat(192 hours)
- Elimination half-life (t1/2)of perindopril parent compound(192 hours)