Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects

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.

Inclusion Criteria: 1. \- Healthy male subjects aged 18 to 55 years. 2. \- Body mass index (BMI) between 18.5 and 30.0 kg/m². 3. \- Clinically healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests. 4. \- Liver function parameters (AST, ALT, total bilirubin, and alkaline phosphatase) within normal limits or considered not clinically significant by the investigator. 5. \- Renal function parameters (serum creatinine and urea) within normal limits or considered not clinically significant by the investigator. 6. \- Able and willing to provide written informed consent prior to participation. 7. \- Able and willing to comply with all study requirements and procedures. Exclusion Criteria: 1. \- Participation in another clinical trial within 6 months prior to enrollment. 2. \- Blood donation within 3 months prior to enrollment. 3. \- History of alcohol or drug abuse. 4. \- Presence of any clinically significant disease identified through medical history, physical examination, laboratory tests, vital signs, or ECG. 5. \- Clinically relevant hepatic or renal impairment. 6. \- History of gastrointestinal disorders that could affect drug absorption. 7. \- Known hypersensitivity or allergy to pomalidomide or any component of the study formulations. 8. \- Use of concomitant medications that could interfere with the pharmacokinetics of pomalidomide. 9. \- Any laboratory abnormality considered clinically significant by the investigator.