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

NCT07694011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

  • Pomalidomide Bioequivalence Study in Healthy Volunteers

Interventions

DRUG

Xetrane® (Pomalidomide) 4 mg Hard Capsule

Test formulation

DRUG

Imnovid® (Pomalidomide) 4 mg Hard Capsule

Reference formulation

Sponsors & Collaborators

  • Laboratorio LKM Chile SpA (Knight Therapeutics Company)

    collaborator UNKNOWN

  • Knight Therapeutics (USA) Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2025-02-05
Completion
2025-02-07

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694011 on ClinicalTrials.gov