- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01313793
A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804
27 juni 2011 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A bioequivalence (BE) study between two formulations of PF-00299804.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bruxelles, Belgien, B-1070
- Pfizer Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Plasma AUCinf of of PF 00299804
Tidsram: 6-8 weeks
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6-8 weeks
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AUClast of PF 00299804
Tidsram: 6-8 weeks
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6-8 weeks
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Cmax of PF 00299804
Tidsram: 6-8 weeks
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6-8 weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Plasma AUCinf of PF 00299804.
Tidsram: 6-8 weeks
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6-8 weeks
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CL/F of PF 00299804.
Tidsram: 6-8 weeks
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6-8 weeks
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Tmax of PF 00299804.
Tidsram: 6-8 weeks
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6-8 weeks
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tlast of PF 00299804.
Tidsram: 6-8 weeks
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6-8 weeks
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t1/2 of PF 00299804.
Tidsram: 6-8 weeks
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6-8 weeks
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Plasma AUCinf of PF-05199265
Tidsram: 6-8 weeks
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6-8 weeks
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AUClast of PF-05199265
Tidsram: 6-8 weeks
|
6-8 weeks
|
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Cmax of PF-05199265
Tidsram: 6-8 weeks
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6-8 weeks
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Tmax of PF-05199265
Tidsram: 6-8 weeks
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6-8 weeks
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tlast of PF-05199265
Tidsram: 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
Tidsram: 6-8 weeks
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6-8 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2011
Primärt slutförande (Faktisk)
1 maj 2011
Avslutad studie (Faktisk)
1 maj 2011
Studieregistreringsdatum
Först inskickad
8 februari 2011
Först inskickad som uppfyllde QC-kriterierna
10 mars 2011
Första postat (Uppskatta)
14 mars 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 juni 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juni 2011
Senast verifierad
1 juni 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- A7471022
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .