Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects (PRO-BEQ-PMD-00)

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

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.

Study Overview

• Status: Completed
• Conditions: Pomalidomide Bioequivalence Study in Healthy Volunteers
• Intervention / Treatment: Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule; Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Chile
  • Providencia
    • Santiago, Providencia, Chile
      • Domínguez Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xetrane® → Imnovid®; Participants received a single oral dose of Xetrane® (pomalidomide) 4 mg hard capsule under fasting conditions in Period 1, followed by a 7-day washout period and a single oral dose of Imnovid® (pomalidomide) 4 mg hard capsule under fasting conditions in Period 2.	Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule; Test formulation; Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule; Reference formulation
Experimental: Imnovid® → Xetrane®; Participants received a single oral dose of Imnovid® (pomalidomide) 4 mg hard capsule under fasting conditions in Period 1, followed by a 7-day washout period and a single oral dose of Xetrane® (pomalidomide) 4 mg hard capsule under fasting conditions in Period 2.	Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule; Test formulation; Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule; Reference formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax)	Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.	0 to 48 hours after dosing
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)	Area under the plasma concentration-time curve from time zero to the last measurable concentration following administration of the test and reference formulations.	0 to 48 hours after dosing

Collaborators and Investigators

• Sponsor: Knight Therapeutics (USA) Inc
• Collaborators: Laboratorio LKM Chile SpA (Knight Therapeutics Company)

Publications and helpful links

General Publications

• Laboratorio LKM Chile SpA. RES-BEQ-PMD-002-V.01: Informe de Resultados - Estudio de Biodisponibilidad comparativa de Pomalidomida en voluntarios sanos. June 2025.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mechanical Phenomena; Physical Phenomena; pomalidomide; Hardness
• Other Study ID Numbers: Knight Therapeutics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available because the study was conducted for regulatory bioequivalence purposes and contains participant-level clinical and pharmacokinetic information subject to confidentiality and privacy protections. Aggregate study results are reported in the study publication and regulatory submissions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No