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A Bioequivalence Study of 15 mg ER OROS Paliperidone

6. juni 2011 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Pivotal Bioequivalence Study With 15 mg ER OROS Paliperidone Comparing the Phase 3 Formulation With the To-be-marketed Formulation and Evaluation of Food Effect on the to be Marketed Formulation in Healthy Male Subjects

The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed tablet strength. Additionally, the safety and tolerability of the treatments in healthy volunteers will be assessed.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is designed as a single-center, open-label, randomized, 3 treatment-period, crossover study in healthy male adults. The study consists of a screening phase and an open-label treatment phase during which each volunteer will receive 3 treatments of study drug in a random order and separated by a washout period of 10 to 14 days. Treatment A consists of a single oral dose of 15 mg ER OROS paliperidone Phase 3 formulation in the fasted state; Treatment B consists of a single oral dose of 15 mg ER OROS paliperidone to-be-marketed formulation in fasted state; and Treatment C consists of a single oral dose of 15 mg ER OROS paliperidone to-be-marketed formulation after consumption of a high-fat breakfast. There are slight formulation differences between the ER OROS paliperidone formulation that was used in Phase 3 efficacy studies and the formulation that is intended to be marketed. What is more important, however, is that the highest tablet strength used in Phase 3 and the tablet strength that is planned for the market as commercial formulation are different. For Phase 3 studies, 9 mg was the highest tablet strength and the highest dose of 15 mg was administered as 2 tablets of 3 mg and 1 tablet of 9 mg. The highest to-be-marketed tablet strength is 15 mg. This study is designed to demonstrate the bioequivalence between the Phase 3 formulation and the highest tablet strength of the to-be-marketed formulation and to assess the effect of food on the highest to-be-marketed tablet strength. Safety and tolerability will be monitored throughout the study. All volunteers will receive each of the following 3 treatments in the order specified by the random assignment:Treatment A, oral ER OROS paliperidone Phase 3 formulation as 2 tablets of 3 mg and 1 tablet of 9 mg in the fasted state; Treatment B, oral ER OROS paliperidone to-be-marketed formulation as 1 tablet of 15 mg in the fasted state; Treatment C, oral ER OROS paliperidone to-be-marketed formulation as 1 tablet of 15 mg after a high-fat breakfast.

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Body Mass Index (weight [kg]/height [m²]) of 18 to 28 kg/m², inclusive
  • Have a supine (after 5 minutes rest) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 50 to 90 mmHg diastolic, inclusive
  • Healthy on the basis of a prestudy physical examination, medical history, ECG, and the laboratory results of serum chemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the serum chemistry, hematology or urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only if the investigator judges that the deviations are not clinically significant. For renal function tests, the values must be within the normal laboratory reference ranges.

Exclusion Criteria:

  • Drug allergy to risperidone, paliperidone, or any of its excipients
  • Known allergy or history of significant hypersensitivity to heparin, in case a heparin lock will be used
  • Recent history of alcohol or substance abuse, a positive test result for the urine drug screen at screening or upon admittance to the testing facility or a positive result for the alcohol urine test upon admittance to the testing facility
  • Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic or immunologic disease
  • History of any cancer, with the exception of basal cell carcinoma
  • At screening, has a sustained decrease of >20 mmHg in systolic blood pressure or a decrease of >10 mmHg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
  • Bradycardia (heart rate <50 bpm) as determined by screening ECG
  • History of or a positive test result for any of the serology tests (hepatitis B, C, and HIV)
  • History of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. Volunteers must agree to refrain from use throughout the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
To evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of ER OROS paliperidone and to evaluate the effect of food on the highest to-be-marketed tablet strength

Sekundære resultatmål

Resultatmål
For å evaluere sikkerheten og toleransen til behandlingene hos friske frivillige

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2004

Studiet fullført (Faktiske)

1. desember 2004

Datoer for studieregistrering

Først innsendt

18. desember 2008

Først innsendt som oppfylte QC-kriteriene

30. april 2009

Først lagt ut (Anslag)

4. mai 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. juni 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2011

Sist bekreftet

1. mars 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR004213

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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