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Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects (PRO-BEQ-PMD-00)

8. juli 2026 opdateret af: Knight Therapeutics (USA) Inc

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Chile
    • Providencia
      • Santiago, Providencia, Chile
        • Domínguez Lab

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. - Healthy male subjects aged 18 to 55 years.
  2. - Body mass index (BMI) between 18.5 and 30.0 kg/m².
  3. - Clinically healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests.
  4. - Liver function parameters (AST, ALT, total bilirubin, and alkaline phosphatase) within normal limits or considered not clinically significant by the investigator.
  5. - Renal function parameters (serum creatinine and urea) within normal limits or considered not clinically significant by the investigator.
  6. - Able and willing to provide written informed consent prior to participation.
  7. - Able and willing to comply with all study requirements and procedures.

Exclusion Criteria:

  1. - Participation in another clinical trial within 6 months prior to enrollment.
  2. - Blood donation within 3 months prior to enrollment.
  3. - History of alcohol or drug abuse.
  4. - Presence of any clinically significant disease identified through medical history, physical examination, laboratory tests, vital signs, or ECG.
  5. - Clinically relevant hepatic or renal impairment.
  6. - History of gastrointestinal disorders that could affect drug absorption.
  7. - Known hypersensitivity or allergy to pomalidomide or any component of the study formulations.
  8. - Use of concomitant medications that could interfere with the pharmacokinetics of pomalidomide.
  9. - Any laboratory abnormality considered clinically significant by the investigator.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Xetrane® → Imnovid®
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.
Medicin: Xetrane® (Pomalidomide) 4 mg Hard Capsule
Test formulation
Medicin: Imnovid® (Pomalidomide) 4 mg Hard Capsule
Reference formulation
Eksperimentel: Imnovid® → Xetrane®
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.
Medicin: Xetrane® (Pomalidomide) 4 mg Hard Capsule
Test formulation
Medicin: Imnovid® (Pomalidomide) 4 mg Hard Capsule
Reference formulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Plasma Concentration (Cmax)
Tidsramme: 0 to 48 hours after dosing
Maximum observed plasma concentration of pomalidomide following administration of the test and reference formulations.
0 to 48 hours after dosing
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Tidsramme: 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.
0 to 48 hours after dosing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Knight Therapeutics (USA) Inc

Samarbejdspartnere

Laboratorio LKM Chile SpA (Knight Therapeutics Company)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • Laboratorio LKM Chile SpA. RES-BEQ-PMD-002-V.01: Informe de Resultados - Estudio de Biodisponibilidad comparativa de Pomalidomida en voluntarios sanos. June 2025.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. januar 2025

Primær færdiggørelse (Faktiske)

5. februar 2025

Studieafslutning (Faktiske)

7. februar 2025

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Knight Therapeutics

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Xetrane® (Pomalidomide) 4 mg Hard Capsule

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