CTRI/2025/09/095472尚未招募不适用
An Open-Label, Balanced, Randomized, Multi-Center, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Two-Way Crossover, Oral Bioequivalence Study of Hydroxyurea Capsules, USP 500 Mg (Test Product) Compared with Hydrea® (Hydroxyurea Capsules, USP) 500 Mg (Reference Product) in Adult, Human Patients with Sickle Cell Anemia Under Fasting Conditions.
Esjay Pharma Pvt. Ltd.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To assess the oral bioequivalence of Hydroxyurea Capsules, USP 500 mg (T) with HYDREA® (Hydroxyurea Capsules, USP) 500 mg (R) in adult, human patients with sickle cell anemia under fasting conditions.
研究概览
简要总结
The study will be an open labelled, randomized, multicenter, single dose, two treatments, two periods, two sequence, two-way cross-over oral bioequivalence study. A total of 36 Sickle Cell Anemia patients will be included based on inclusion exclusion criteria. The study duration will be about 10 days per patient (from Day 00 of Period 1 check-in to Day09 period 02 checkout) including washout period (interval between 2 drug administrations) of at least by 07 days. The screening will be performed within 28 days before period 01 check-in. Study drug will be administered with 240 mL of water as per the randomization. Blood samples will be collected in scheduled time points. During study patient safety assessment (physical exam, temperature, BP, pulse rate) will be measured and post study clinical lab assessment will be performed for all the dosed patients. Bioanalysis will be done using validated method. Pharmacokinetic analysis will be performed using Phoenix® WinNonlin® software and statistical analysis will be performed using SAS® system. The study is not published in any literature or online journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •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
- •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
- •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
- •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
- •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
- •Non-smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months
- •Patients having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording
- •Patients having a normal or clinically not significant chest X-Ray.
- •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.
排除标准
- •History of hypersensitivity to hydroxyurea or any other component of its formulation as judged by the investigator
- •History of a myeloproliferative disease, diffuse pulmonary infiltrates or pulmonary fibrosis
- •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
- •History of therapy with interferon or antiretroviral agents (e.g. didanosine, stavudine and indinavir) within 28 days before the first administration of investigational product
- •Patients with leukemia of any type
- •Uncontrolled systemic infection
- •Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia
- •History of drug/alcohol addiction
- •Pregnant or lactating females
- •Patients found to be positive for HIV, Hepatitis B or C, VDRL at screening visit
- •Patients requiring dosing with any of the live vaccines.
- •Patients suffering from gout
- •Patients with skin cancer or other secondary malignancies
- •Patients with cutaneous vasculitic toxicities, including vasculitic ulcerations, gangrene, etc
- •Patients with history of diagnosis of macrocytosis or pernicious anemia
- •following treatment with hydroxyurea
- •Donation of blood or any blood loss within 90 days prior to receiving the first dose of study drug
- •Inadequate venous access for PK sampling as judged by investigator
- •Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period
- •Use of any OTC medicinal products (including herbal remedies) during the 05 days prior to check-in and inability to abstain during the study
- •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
- •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
- •Patients found positive on urine scan for drugs of abuse and/or breath / other relevant test for alcohol consumption at study site check-in
- •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
- •Patients with any significant history of non-compliance or inability to reliably grant informed consent
- •Significant blood loss/hemorrhage leading to hemodynamic instability as judged by Investigator
- •Patients with difficulty in swallowing the study drug.
结局指标
主要结局
To assess the oral bioequivalence of Hydroxyurea Capsules, USP 500 mg (T) with HYDREA® (Hydroxyurea Capsules, USP) 500 mg (R) in adult, human patients with sickle cell anemia under fasting conditions.
时间窗: PK samples will be collected at day 2 of visit 2 and day 2 of visit 3
次要结局
- To monitor the safety and tolerability of a single dose of an Investigational Product in adult, human patients with sickle cell anemia under fasting conditions.(PK samples will be collected at day 2 of visit 2 and day 2 of visit 3)
研究者
Dr Shanmugarajan
Scitus Pharma Services Private Limited
研究点 (2)
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