- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00645554
A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers
18 maj 2011 uppdaterad av: Xian-Janssen Pharmaceutical Ltd.
A Bioequivalent Study to Compare Galantamine Oral Solution With Marketed Galantamine Capsule After Single Oral Administration of 10 mg.
The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.
All patients are healthy male patients who are 18-45 years old with BWI (Body Weight Index) between 18-28 kg/m2.
All patients must sign informed consent before being enrolled.
24 patients were randomized in the study.
The duration of study is 9 days.
All patients must stay at site unit for 12 hours after single oral administration otherwise patients could stay home but must return to site at specific date and time.
The day before dosing day (baseline), patients were randomized to one of the two groups to be administered either 4mg galantamine oral solution (1ml) or galantamine tablet (1 tablet).
After 7-day washout period, patients were crossed over to receive the other formulation.
Pharmacokinetic observation will last to 32 hours after dosing.
Plasma were collected at immediately before dosing and 0.25, 0.5, 0.75, 1.5, 2, 3, 4, 6, 8, 12, 24 and 32 hours after dosing to determine plasma concentration of galantamine.
Safety and tolerance evaluation will last until Day 9. Safety evaluation include adverse events, vital signs, physical examination, electrocardiogram and laboratory tests.
On study Day 1, patients will take either 4mg galantamine oral solution (1ml) or 4mg galantamine tablet (1 tablet).
After 7-day washout period, on Day 8, patients will cross over to take the other formulation, the dosage and administration are the same.
Studietyp
Interventionell
Inskrivning (Faktisk)
2
Fas
- Fas 1
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 48 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- All patients must meet the following criteria: body weight index is between 18-28 kg/m2
- Patients are deemed healthy based on physical examination, medical history, vital signs, electrocardiogram and results of clinical laboratory tests
- All patients must be able to read and understand the contents of informed consent that must be signed prior to any trial-specific procedures are done.
Exclusion Criteria:
- Patients meeting one or more of the following criteria cannot be included in the study: the patient uses disallowed medicine, which is any prescribed medication within the last 2 weeks or OTC drugs within the last week prior to dosing (or at least 5 half lives for any drug ingested). Patients who have taken any non-prescribed systemic or topical medication may still be entered into the study, if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety
- The subject has history of alcohol or drug abuse
- Patient has been treated with an investigational drug within 30 days prior to screening
- Patient has a know hypersensitivity to galantamine or has a history of severe drug allergy or hypersensitivity
- Patient has any serious illness such as liver or renal insufficiency, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, metabolic and other chronic disturbance
- Patient has donated blood within 60 days prior to dosing
- Patient is a moderate or severe smoker who smokes more than 3 cigarettes, or ex-smokers who has ceased smoking for at least 3 months prior to dosing
- Patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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It is estimated that the plasma maximal concentration of galantamine (Cmax=31.53mg×L-1) after single oral administration can be reached in Chinese young volunteers at the peak time of 1.66 hours. The half life is 7.06 hours.
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Sekundära resultatmått
Resultatmått |
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The relative bioavialibility of galantamine oral solution (4mg) indicated by AUC0-t and AUC0-inf are 105.6%±18.5% and 106.2%±19.5% respectively.
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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
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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
Avslutad studie (Faktisk)
1 september 2004
Studieregistreringsdatum
Först inskickad
24 mars 2008
Först inskickad som uppfyllde QC-kriterierna
24 mars 2008
Första postat (Uppskatta)
27 mars 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 maj 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2011
Senast verifierad
1 mars 2010
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR002848
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 .