- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01769677
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
19. März 2013 aktualisiert von: Teva Branded Pharmaceutical Products R&D, Inc.
A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of Two 45-mg and One 90-mg Hydrocodone Bitartrate Extended-Release Tablet
The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
54
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Texas
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Austin, Texas, Vereinigte Staaten
- Teva Investigational Site 10470
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Written informed consent is obtained.
- The subject can read, speak, and write in English.
- The subject is a man or woman 18 through 45 years of age, with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive.
- The subject is in good health as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, urinalysis, and serology.
- Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using an acceptable method of contraception, and agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
- The subject has a negative alcohol test and urine drug screen.
- The subject must be willing and able to comply with study restrictions and to remain at the study center for the required duration of each study drug period during the study.
Exclusion Criteria:
- The subject has any clinically significant uncontrolled medical conditions (treated or untreated).
- The subject has a clinically significant deviation from normal in ECG or physical examination findings, as determined by the investigator or the medical monitor.
- The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). NOTE: A unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer.
- The subject is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including GI surgery; a history of appendectomy is allowed).
- The subject has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug.
- The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, their related compounds, or to any metabolites, or naltrexone, or any compound listed as being present in a study formulation.
- Other exclusion criteria apply.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Treatment Group AB
Subjects in this group will receive study drug in the following sequence:
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Each subject will receive 1 treatment during each administration period.
Subjects will receive each of the 2 treatments once.
There will be a minimum 14-day washout period between the 2 administrations of study drug.
Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
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Experimental: Treatment Group BA
Subjects in this group will receive study drug in the following sequence:
|
Each subject will receive 1 treatment during each administration period.
Subjects will receive each of the 2 treatments once.
There will be a minimum 14-day washout period between the 2 administrations of study drug.
Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Maximum observed plasma drug concentration (Cmax)
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To assess the bioequivalence between 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Area under the plasma drug concentration by time curve AUC0-∞
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To assess bioequivalence between two 45-mg tablets and one 90-mg tablet of the hydrocodone bitartrate extended-release tablet.
|
Up to 72 hrs after each dose of study drug
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to maximum observed plasma drug concentration (tmax)
Zeitfenster: Up to 72 hrs after each dose of study drug
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To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
|
AUC from time 0 to 72 hours after study drug administration (AUC0-72)
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
|
Up to 72 hrs after each dose of study drug
|
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
|
Up to 72 hrs after each dose of study drug
|
Percentage extrapolation, 100x(AUC0-∞-AUC0-t)/AUC0-∞)
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
|
Up to 72 hrs after each dose of study drug
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Apparent plasma terminal elimination rate constant (λz) and associated elimination half life (t½)
Zeitfenster: Up to 72 hrs after each dose of study drug
|
To characterize the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
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Up to 72 hrs after each dose of study drug
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Recording of Adverse Events
Zeitfenster: Adverse events will be collected for the duration of the study which is approximately 7 weeks
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To characterize the safety of the hydrocodone bitartrate extended-release tablet in healthy naltrexone-blocked subjects.
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Adverse events will be collected for the duration of the study which is approximately 7 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2013
Primärer Abschluss (Tatsächlich)
1. Januar 2013
Studienabschluss (Tatsächlich)
1. Februar 2013
Studienanmeldedaten
Zuerst eingereicht
10. Januar 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Januar 2013
Zuerst gepostet (Schätzen)
17. Januar 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
20. März 2013
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. März 2013
Zuletzt verifiziert
1. März 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C33237/1099
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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