Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- AUClast
研究概览
简要总结
The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.
详细描述
It is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). Of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of Phase I. So the study was initiated and completed with the participation of 27 volunteers. The volunteers were in hospital for a period of approximately 36 hours in each stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Considered healthy after undergoing a clinical evaluation;
- •Agree freely and sign the Recruitment and Informed Consent Term, after all the content of the protocol was clear before any procedure;
- •Present the body mass index greater than 19 and less than 30.
排除标准
- •Results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant;
- •Allergic to lamivudine or any other drug;
- •Positive outcome of the pre-admission pregnancy test;
- •Regular medication within four (4) weeks prior to the start of the study or use of any medication to present interaction with lamivudine one week before the start of the study;
- •Use abusive alcoholic beverage;
- •Use of illicit drugs and tobacco;
- •History of liver disease, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric; hypo- or hypertension of any cause that required pharmacological treatment; myocardial infarction, angina and / or heart failure;
研究组 & 干预措施
Period 1
Epivir ® tablet 150-mg single dose (drug reference)
干预措施: Epivir ® tablet 150-mg single dose (drug reference) (Drug)
Period 1
Epivir ® tablet 150-mg single dose (drug reference)
干预措施: Lamivudine 150-mg tablet single dose (drug test) (Drug)
Period 2
Lamivudine 150-mg tablet single dose (drug test)
干预措施: Epivir ® tablet 150-mg single dose (drug reference) (Drug)
Period 2
Lamivudine 150-mg tablet single dose (drug test)
干预措施: Lamivudine 150-mg tablet single dose (drug test) (Drug)
结局指标
主要结局
AUClast
时间窗: Up to 36 hours
Area under the Plasma concentration-time curve from time Zero to last time (AUCinf) of lamivudine in plasma.
次要结局
- T1/2(Up to 72 hours)
- Cmax(Up to 36 hours)
- AUCinf(Up to 36 hours)
- Tmax(Up to 36 hours)
研究者
José Homero de Souza Filho
Principal Investigator
Universidade Federal de Pernambuco