Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Eliquis® 5 mg Film Coated Tablet, Bristol-Myers Squibb Company, Puerto Rico, Packed and Released By Bristol-Myers Squibb S.R.L., Italy, Imported by PT Pfizer Indonesia)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC(0-t)
研究概览
简要总结
This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects. The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia).
详细描述
The objective of this study was to find out whether the bioavailability of apixaban 5 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Eliquis® 5 mg filmcoated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia). This was an open-label, randomized, single dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects. The participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally the test drug (apixaban 5 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Eliquis® 5 mg Film Coated Tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia) with 200 mL of water. The subject's oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, and 48.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of apixaban following single dose administration. The plasma concentrations of apixaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-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
- Other
- 盲法
- None
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
- •Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- •Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
- •Aged 18 - 55 years inclusive.
- •Preferably non-smokers or smoke less than 10 cigarettes per day.
- •Body mass index within 18 to 25 kg/m
- •Normal prothrombin time (PT) and normal partial thromboplastin time (aPTT)
- •Creatinine clearance > 50 mL/min
- •Vital signs (after 10 minutes rest) must be within the following ranges:
- •Systolic blood pressure: 100 - 129 mmHg
- •Diastolic blood pressure: 60 - 84 mmHg
- •Pulse rate: 60 - 90 bpm.
排除标准
- •History of allergy or hypersensitivity or contraindication to apixaban or factor Xa inhibitors or allied drug.
- •Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
- •Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- •Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- •Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
- •Clinically significant hematology abnormalities.
- •Positive result for COVID-19 antigen rapid test.
- •Clinically significant electrocardiogram (ECG) abnormalities.
- •Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
- •Past history of anaphylaxis or angioedema.
- •History of drug or alcohol abuse within 12 months prior to screening for this study.
- •Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
- •History of any bleeding or coagulative disorders.
- •History of significant head injury within the last two years.
- •Presence of difficulty in accessibility of veins in left or right arm.
- •A donation or significant blood loss within 90 days before this study's first dosing day.
- •Intake of any prescription, (especially apixaban, other anticoagulants, azole antimycotics), non-prescription drug, (including hormonal contraception), food supplements or herbal medicines within 21 days of this study's first dosing day
研究组 & 干预措施
Test Apixaban 5 mg Film-Coated Tablet PT Dexa Medica
Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)
干预措施: Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica) (Drug)
Reference Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb
Eliquis® 5 mg film-coated tablet, Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia
干预措施: Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia) (Drug)
结局指标
主要结局
AUC(0-t)
时间窗: 48 hours
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
Cmax
时间窗: 48 hours
Maximum plasma concentration
次要结局
- T1/2(48 hours)
- Tmax(48 hours)
- AUC(0-inf)(48 hours)