A Randomized, Open Label, Two-Treatment, Single Dose, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Hydroxyurea Capsules 500 mg of Blau Farmaceutica, Brazil with Hydrea (Hydroxyurea Capsules) 500 mg of Brystol-Myers Squibb Co., Brazil in Adult Patients Suffering from Sickle Cell Anemia under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Assess Bioequivalence of the investigational product versus comparator product
研究概览
简要总结
Hydroxyurea stimulates the production of fetal hemoglobin in patients with sickle cell Anemia (SCA), which inhibits sickling. In a randomized placebo controlled study of adults with SCA, hydroxyurea has been reported to decrease the rates of vasoocclusive crisis, acute chest syndrome, and blood transfusion, leading regulatory authorities to approve hydroxyurea for the treatment of SCA in adults. In children with SCA, hydroxyurea treatment has been reported to significantly reduce the number of days spent in hospital and confirmed this beneficial effect. In addition to increased production of fetal hemoglobin, decreased endothelial adhesiveness and increased bioavailability of nitric oxide may mediate the therapeutic effects of hydroxyurea.
Sponsor has developed generic version of hydroxyurea capsules 500 mg. The present study aims to evaluate bioequivalence of sponsor’s test formulation against corresponding reference product in adult patients, who are diagnosed to have Sickle Cell Anemia.
**Primary objective:**To characterize pharmacokinetic profile of Test product –hydroxyurea capsules 500 mg of Blau Farmaceutica, Brazil, compared to that of the corresponding Reference product – Hydrea (hydroxyurea capsules) 500 mg of Bristol-Myers Squibb Co., Brazil under fasting conditions in adult patients, who are diagnosed to have Sickle Cell Anemia, and assess the bioequivalence.
Secondary Objective: To monitor the safety and tolerability of a single dose of hydroxyurea capsules 500 mg in adult patients, who are diagnosed to have Sickle Cell Anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 45 years (both inclusive) and either sex.
- •Diagnosed case of sickle cell anemia and not being treated with hydroxyurea.
- •Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
- •Females of childbearing potential must have a negative beta-HCG pregnancy test as well as must be non-lactating at Screening and must agree to use an effective contraceptive method during study.
排除标准
- •History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator.
- •Abnormal laboratory results as below: • SGOT &/or SGPT greater than 3 times upper limit of normal (ULN) • Serum Creatinine greater than 3 times ULN • Platelet Count less than 95,000/mm3 • Absolute neutrophils count less than 2500/ mm3 • Reticulocyte count less than 95,000/mm3 • Reactive for HIV antibody, HBsAg or HCV antibody
- •History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis.
- •History of therapy with interferon or antiretroviral agents (e.g. didanosine, stavudine and indinavir) within 28 days before the first administration of Investigational Product.
- •Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory information needed to achieve the objectives of the study.
- •Alcohol or any drug dependence within past one year.
- •Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
- •Blood donation/ loss exceeding 200 ml within last 60 days.
结局指标
主要结局
Assess Bioequivalence of the investigational product versus comparator product
时间窗: Day 01 and Day 08.
次要结局
- Safety and tolerability of single dose of the investigational product versus comparator product(Throughout the study period till follow-up on day 15)