An Open-Label, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence and Tolerability of Xetrane® 4 mg Hard Capsules and Imnovid® 4 mg Hard Capsules in Healthy Male Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane® 4 mg hard capsule) compared with the reference formulation (Imnovid® 4 mg hard capsule) in healthy male subjects under fasting conditions. The study used an open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover design. Pharmacokinetic parameters including Cmax and AUC0-t were compared between formulations. Bioequivalence was concluded if the 90% confidence intervals for the geometric mean ratios of the log-transformed pharmacokinetic parameters were within the predefined acceptance range of 80.00% to 125.00%. Safety and tolerability were also assessed.
详细描述
This was a single-center, randomized, open-label, single-dose, two-period crossover bioequivalence study conducted in healthy male subjects. Participants received a single oral dose of either Xetrane® (pomalidomide 4 mg hard capsule) or Imnovid® (pomalidomide 4 mg hard capsule) under fasting conditions, followed by a 7-day washout period and crossover administration of the alternate treatment.
Blood samples were collected up to 48 hours post-dose for determination of plasma pomalidomide concentrations using a validated LC-MS/MS method. Pharmacokinetic parameters were calculated using non-compartmental analysis.
The primary objective was to compare the rate and extent of absorption of the two formulations through Cmax and AUC0-t. Secondary objectives included assessment of AUC0-inf, Tmax, elimination half-life (t1/2), elimination rate constant (Kel), and safety and tolerability.
A total of 34 healthy male subjects were enrolled, and 29 completed both study periods and were included in the pharmacokinetic analysis. The study demonstrated bioequivalence between the test and reference products, with 90% confidence intervals for Cmax and AUC0-t fully contained within the regulatory acceptance range of 80.00%-125.00%. Both formulations were generally well tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- Healthy male subjects aged 18 to 55 years.
- •- Body mass index (BMI) between 18.5 and 30.0 kg/m².
- •- Clinically healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests.
- •- Liver function parameters (AST, ALT, total bilirubin, and alkaline phosphatase) within normal limits or considered not clinically significant by the investigator.
- •- Renal function parameters (serum creatinine and urea) within normal limits or considered not clinically significant by the investigator.
- •- Able and willing to provide written informed consent prior to participation.
- •- Able and willing to comply with all study requirements and procedures.
排除标准
- •- Participation in another clinical trial within 6 months prior to enrollment.
- •- Blood donation within 3 months prior to enrollment.
- •- History of alcohol or drug abuse.
- •- Presence of any clinically significant disease identified through medical history, physical examination, laboratory tests, vital signs, or ECG.
- •- Clinically relevant hepatic or renal impairment.
- •- History of gastrointestinal disorders that could affect drug absorption.
- •- Known hypersensitivity or allergy to pomalidomide or any component of the study formulations.
- •- Use of concomitant medications that could interfere with the pharmacokinetics of pomalidomide.
- •- Any laboratory abnormality considered clinically significant by the investigator.
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: 0 to 48 hours after dosing
Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
时间窗: 0 to 48 hours after dosing
Area under the plasma concentration-time curve from time zero to the last measurable concentration following administration of the test and reference formulations.
次要结局
未报告次要终点