- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01313793
A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804
27. juni 2011 opdateret af: Pfizer
A Phase 1 Open-Label Study Of Pf-00299804 In Healthy Volunteers To Demonstrate The Bioequivalence Of The Proposed Commercializable Formulation Administered As One 45-Mg Tablet Relative To Three 15-Mg Clinical Formulation Tablets
The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation.
Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A bioequivalence (BE) study between two formulations of PF-00299804.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bruxelles, Belgien, B-1070
- Pfizer Investigational Site
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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
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects including males between the ages of 18 and 55 years and/or females of non childbearing potential between the ages of 18 and 55 years. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- Use of tobacco- or nicotine- containing products (or a positive urine drug cotinine test).
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication.
- 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
- Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication. Depo Provera must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Sequence 1
Subjects will receive clinical formulation (treatment A) followed by commercializable formulation (treatment B).
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Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.
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Eksperimentel: Sequence 2
Subjects will receive commercializable formulation (treatment B) followed by clinical formulation (treatment A).
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Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Plasma AUCinf of of PF 00299804
Tidsramme: 6-8 weeks
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6-8 weeks
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AUClast of PF 00299804
Tidsramme: 6-8 weeks
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6-8 weeks
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Cmax of PF 00299804
Tidsramme: 6-8 weeks
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6-8 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Plasma AUCinf of PF 00299804.
Tidsramme: 6-8 weeks
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6-8 weeks
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CL/F of PF 00299804.
Tidsramme: 6-8 weeks
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6-8 weeks
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Tmax of PF 00299804.
Tidsramme: 6-8 weeks
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6-8 weeks
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tlast of PF 00299804.
Tidsramme: 6-8 weeks
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6-8 weeks
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t1/2 of PF 00299804.
Tidsramme: 6-8 weeks
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6-8 weeks
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Plasma AUCinf of PF-05199265
Tidsramme: 6-8 weeks
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6-8 weeks
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AUClast of PF-05199265
Tidsramme: 6-8 weeks
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6-8 weeks
|
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Cmax of PF-05199265
Tidsramme: 6-8 weeks
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6-8 weeks
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Tmax of PF-05199265
Tidsramme: 6-8 weeks
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6-8 weeks
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tlast of PF-05199265
Tidsramme: 6-8 weeks
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6-8 weeks
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Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring
Tidsramme: 6-8 weeks
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6-8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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
1. april 2011
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
8. februar 2011
Først indsendt, der opfyldte QC-kriterier
10. marts 2011
Først opslået (Skøn)
14. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- A7471022
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 .
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