A Phase 1 interventional study of Xetrane® (Pomalidomide) 4 mg Hard Capsule and Imnovid® (Pomalidomide) 4 mg Hard Capsule in Pomalidomide Bioequivalence Study in Healthy Volunteers, sponsored by Knight Therapeutics (USA) Inc. Completed at 1 site in Chile. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Knight Therapeutics (USA) Inc · Phase 1, Interventional, and Treatment
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.
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.
Knight Therapeutics (USA) Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule
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 · Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule
Test formulation
Reference formulation
Maximum Plasma Concentration (Cmax)
Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.
Time frame: 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.
Time frame: 0 to 48 hours after dosing
Plan to share: No — 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.
Ran from Jan 2025 to primary completion in Feb 2025, 0 months.
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Studies of the drug tested here: Pomalidomide
Knight Therapeutics (USA) Inc