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Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects
Sponsor: Knight Therapeutics (USA) Inc
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.
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2025-01-25
Completion Date
2025-02-07
Last Updated
2026-07-09
Healthy Volunteers
Yes
Interventions
Test formulation
Xetrane® (Pomalidomide) 4 mg Hard Capsule
Reference
Imnovid® (Pomalidomide) 4 mg Hard Capsule
Locations (1)
Domínguez Lab
Santiago, Providencia, Chile