Pomalidomide Bioequivalence Study in Healthy VolunteersPhase 1PRO-BEQ-PMD-00NCT07694011
Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects
A Phase 1 study testing Xetrane® (Pomalidomide) 4 mg Hard Capsule and Imnovid® (Pomalidomide) 4 mg Hard Capsule in people with Pomalidomide Bioequivalence Study in Healthy Volunteers, run by Knight Therapeutics (USA) Inc at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pomalidomide Bioequivalence Study in Healthy Volunteers
- What is being tested?
- Xetrane® (Pomalidomide) 4 mg Hard Capsule and Imnovid® (Pomalidomide) 4 mg Hard Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChile
- Study dates
- 25 Jan 2025to 7 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Healthy male subjects aged 18 to 55 years.
- - Body mass index (BMI) between 18.5 and 30.0 kg/m².
- - Clinically healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests.
- - Liver function parameters (AST, ALT, total bilirubin, and alkaline phosphatase) within normal limits or considered not clinically significant by the investigator.
- - Renal function parameters (serum creatinine and urea) within normal limits or considered not clinically significant by the investigator.
- - Able and willing to provide written informed consent prior to participation.
- - Able and willing to comply with all study requirements and procedures.
Who cannot join
- - Participation in another clinical trial within 6 months prior to enrollment.
- - Blood donation within 3 months prior to enrollment.
- - History of alcohol or drug abuse.
- - Presence of any clinically significant disease identified through medical history, physical examination, laboratory tests, vital signs, or ECG.
- - Clinically relevant hepatic or renal impairment.
- - History of gastrointestinal disorders that could affect drug absorption.
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- - Known hypersensitivity or allergy to pomalidomide or any component of the study formulations.
- - Use of concomitant medications that could interfere with the pharmacokinetics of pomalidomide.
- - Any laboratory abnormality considered clinically significant by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Xetrane® (Pomalidomide) 4 mg Hard Capsule, Imnovid® (Pomalidomide) 4 mg Hard Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xetrane® (Pomalidomide) 4 mg Hard CapsuleDrug
Test formulation
Imnovid® (Pomalidomide) 4 mg Hard CapsuleDrug
Reference formulation
| Study group | Role | What they receive |
|---|---|---|
| Xetrane® → Imnovid® | Experimental | 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. Receives: Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule; Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule |
| Imnovid® → Xetrane® | Experimental | 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. Receives: Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule; Drug: Imnovid® (Pomalidomide) 4 mg Hard Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.
Measured: 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.
Measured: 0 to 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start25 Jan 2025
- Primary completion5 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pomalidomide Bioequivalence Study in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knight Therapeutics (USA) Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorio LKM Chile SpA (Knight Therapeutics Company)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694011
- Sponsor's protocol ID
- Knight Therapeutics
- Acronym
- PRO-BEQ-PMD-00
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
Davanco MG, Vespasiano TP, Moisan J, Gonzalez O, Sarmiento M, Groleau M. A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects. Pharmaceuticals (Basel). 2026 Jul 15;19(7):1089. doi: 10.3390/ph19071089.
PubMed 42515769
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07694011
- Acronym / sponsor ID
- PRO-BEQ-PMD-00 / Knight Therapeutics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Knight Therapeutics (USA) IncIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorio LKM Chile SpA (Knight Therapeutics Company)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xetrane® → Imnovid® | Experimental | Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule, Drug: Imnovid® (Pomalidomide) 4 mg Hard CapsuleParticipants 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. |
| Imnovid® → Xetrane® | Experimental | Drug: Xetrane® (Pomalidomide) 4 mg Hard Capsule, Drug: Imnovid® (Pomalidomide) 4 mg Hard CapsuleParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - Healthy male subjects aged 18 to 55 years.
- - Body mass index (BMI) between 18.5 and 30.0 kg/m².
- - Clinically healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests.
- - Liver function parameters (AST, ALT, total bilirubin, and alkaline phosphatase) within normal limits or considered not clinically significant by the investigator.
- - Renal function parameters (serum creatinine and urea) within normal limits or considered not clinically significant by the investigator.
Key exclusion criteria (9 listed)
- - Participation in another clinical trial within 6 months prior to enrollment.
- - Blood donation within 3 months prior to enrollment.
- - History of alcohol or drug abuse.
- - Presence of any clinically significant disease identified through medical history, physical examination, laboratory tests, vital signs, or ECG.
- - Clinically relevant hepatic or renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xetrane® (Pomalidomide) 4 mg Hard CapsuleTest formulation | Drug | Imnovid® → Xetrane®, Xetrane® → Imnovid® |
| Imnovid® (Pomalidomide) 4 mg Hard CapsuleReference formulation | Drug | Imnovid® → Xetrane®, Xetrane® → Imnovid® |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 0 to 48 hours after dosing
Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: 0 to 48 hours after dosing
Area under the plasma concentration-time curve from time zero to the last measurable concentration following administration of the test and reference formulations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Results publicationLaboratorio LKM Chile SpA. RES-BEQ-PMD-002-V.01: Informe de Resultados - Estudio de Biodisponibilidad comparativa de Pomalidomida en voluntarios sanos. June 2025.
- Derived from this study: PubMed 42515769Davanco MG, Vespasiano TP, Moisan J, Gonzalez O, Sarmiento M, Groleau M. A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects. Pharmaceuticals (Basel). 2026 Jul 15;19(7):1089. doi: 10.3390/ph19071089.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xetrane® (Pomalidomide) 4 mg Hard Capsule and Imnovid® (Pomalidomide) 4 mg Hard Capsule in people with Pomalidomide Bioequivalence Study in Healthy Volunteers, run by Knight Therapeutics (USA) Inc at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: 0 to 48 hours after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694011, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.