Health Condition 1: null- Sickle Cell Anemia
Conditions
Interventions
Intervention1: Hydroxyurea capsules 500 mg of Blau Farmaceutica, Brazil: On day 1/ day 8 (as per randomization sequence), the single designated dose (2 x capsule 500 mg e.g. 1000 mg hydroxyurea) will
Sponsors
BLAU FARMACEUTICA
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Bioequivalence of the investigational product versus comparator productTimepoint: Day 01 and Day 08. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single dose of the investigational product versus comparator productTimepoint: Throughout the study period till follow-up on day 15 | — |
Countries
India
Contacts
Public ContactMr Prasann Bavania
Accutest Research Laboratories (I) Pvt. Ltd.
Outcome results
None listed