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.

BLAU FARMACEUTICA0 个研究点目标入组 36 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Age 18 to 45 years (both inclusive) and either sex.
•2. Diagnosed case of sickle cell anemia and not being treated with hydroxyurea.
•3. 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.
•4. 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.

•1. History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator.
•2. 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
•3. History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis.
•4. History of therapy with interferon or antiretroviral agents (e.g. didanosine, stavudine and indinavir) within 28 days before the first administration of Investigational Product.
•5. Any other condition that, in the investigatorâ??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.
•6. Alcohol or any drug dependence within past one year.
•7. Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening.
•8. Blood donation/ loss exceeding 200 ml within last 60 days.

发起方

BLAU FARMACEUTICA