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COMPLETED
NCT07694011
PHASE1

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

Sponsor: Knight Therapeutics (USA) Inc

View on ClinicalTrials.gov

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

DRUG

Test formulation

Xetrane® (Pomalidomide) 4 mg Hard Capsule

DRUG

Reference

Imnovid® (Pomalidomide) 4 mg Hard Capsule

Locations (1)

Domínguez Lab

Santiago, Providencia, Chile