Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Intervention1: Hydroxyurea Tablets 1000 mg - Study group: Single oral dose of Hydroxyurea Tablets 1000 mg with total duration of 10 days
Control Intervention1: Siklos® 1000 mg (Hydroxyurea) -TabletsCo
Sponsors
Esjay Pharma Pvt. Ltd
Scitus Pharma Services Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender (Male or non-pregnant and non-lactating Female) with the age of 18 – 55 years of age with confirmed diagnosis of sickle cell anemia with recurrent painful crises (1 to 6 pain crises in the last 6 months) 2. Patients who are already on a stable dosing regimen of hydroxyurea (1000 mg taken once daily) for at least 24 weeks prior to screening visit in the study 3. Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements 4. Adequate Hematopoietic, Renal and Hepatic function defined as the following Body System Parameters Platelet count greater than or equal to 100,000/mm3 Haemoglobin greater than 9.0 g/dL Hepatic function ALT&AST less than or equal to 2.5 × ULN Total Bilirubin less than or equal to 3.5 mg/dL Renal function Creatinine clearance greater than or equal to 60 ml/min Serum Creatinine less than 3 x ULN Able to comply with study requirement in opinion of Principal Investigator 6. Males of reproductive potential must agree to use effective contraception [including use of barrier methods (male condom, spermicide), behavioral methods (abstinence) or vasectomy] or the female partners of these patients must agree to use an effective method of avoiding pregnancy during the study and for atleast 6 months after the last dose of study drug 7. Females of childbearing potential must have a negative beta-HCG pregnancy test at screening and negative urine pregnancy test at the time of screening and study site check-in . Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] 14 days prior to study drug administration, during study and for atleast 6 months after the last dose of study drug 9. Non-smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months 10. Patients having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording 11. Patients having a normal or clinically not significant chest X-Ray. 12. Patients with Systolic blood pressure between =90 to =140 mmHg and diastolic blood pressure between =60 to = 90 mmHg and heart rate within 60 to 100 bpm at screening & check-in
Exclusion criteria
Exclusion criteria: History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator 2. History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis 3. History of therapy with central nervous system inhibitor or antitumor agents (e.g. 5-fluorouracil) within 28 days before the first administration of investigational product 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. Patients with leukemia of any type 6. Uncontrolled systemic infection 7. Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia 8. History of drug/alcohol addiction 9. Pregnant or lactating females 10. Patients found to be positive for HIV, Hepatitis B or C, VDRL at screening visit 11. Patients requiring dosing with any of the live vaccines. 12. Patients suffering from gout 13. Patients with skin cancer or other secondary malignancies 14. Patients with cutaneous vasculitic toxicities, including vasculitic ulcerations, gangrene, etc 15. Patients with history of diagnosis of macrocytosis or pernicious anemia 16. Patients with a history of tumor lysis syndrome, disorientation, hallucinations, convulsions etc. following treatment with hydroxyurea 17. Patients who have received radiation therapy in the past for any reason 18. Donation of blood or any blood loss within 90 days prior to receiving the first dose of study drug 19. Inadequate venous access for PK sampling as judged by investigator 20. Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period 21. Use of any OTC medicinal products (including herbal remedies) during the 05 days prior to check-in and inability to abstain during the study 22. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs for at least 48.00 hours prior to check-in and inability to abstain during the study 23. Consumption of alcohol and its products, grapefruit and/or its juice and poppy-containing foods within 72.00 hours prior to check-in and inability to abstain during the study 24. Patients found positive on urine scan for drugs of abuse and/or breath / other relevant test for alcohol consumption at study site check-in 25. The receipt of an investigational product or participation in other drug research study within a period of 90 days prior to the first dose of study drug for the current study 26. Patients with any significant history of non-compliance or inability to reliably grant informed consent 27. Significant blood loss/hemorrhage leading to hemodynamic instability as judged by Investigator 28. Patients with difficulty in swallowing the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the oral bioequivalence of Hydroxyurea Tablets 1000 mg (T), with Siklos® 1000 mg (Hydroxyurea) Tablets (R), in adult, human patients with sickle cell anemia under fasting conditions.Timepoint: PK samples will be collected at day 2 of visit 2 and day 2 of visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability of a single dose of an Investigational Product in adult, human patients with sickle cell anemia under fastingconditionsTimepoint: PK samples will be collected at day 2 of visit 2 & day 2 of visit 3 | — |
Countries
India
Contacts
Public ContactDr SD Rajendran
Scitus Pharma Services Private Limited,
Outcome results
None listed