- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01504984
Crossover Study to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab in Healthy Male Volunteers
An Open-label, Randomized, Single Dose, Crossover Phase I Clinical Trial to Compare Pharmacokinetic Property of SYO-1126 and Glivec Film Coated Tab., 4T (400mg) in Healthy Male Volunteers
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYO-1126 and Glivec Film Coated tab 4T (400mg) as of imatinib 400mg.
Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYO-1126 and Glivec Film Coated tab 4T (400mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Seodaemun-gu
-
Seoul, Seodaemun-gu, Korea, Republikken
- Severance Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Between 20aged and 45aged in healthy males
- Over 55kg and BMI: 18.5~25 kg/m2
- Agreement with written informed consent
Exclusion Criteria:
- Subject with symptoms of acute disease at the time of screening
- Clinically significant cardiovascular system, pulmonary system, renal system, endocrine system, blood system, gastrointestinal system, nervous system, mental disease or malignant tumor
- Subject with known for gastrointestinal disease or surgical history which affect on absorption of drug
- An impossible one who participates in clinical trial by result of screening tests
- Inadequate result of laboratory test AST/ALT > 1.5 x UNL Total bilirubin > 1.5 X UNL
- Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- Subject with known for hypersensitivity reaction to imatinib analog
- Subject with known for history which drug abuse or show positive for it in screening tests
- Previously participate in other trial within 60 days
- Previously make whole blood donation within 60 days or component blood donation within 30 days
- Previously have blood transfusion within 30 days
- Not able to taking the institutional standard meal
- Subject who have had abnormal eating which affect on the ADME of drug
- Not able to taking the grapefruit-containing foods
- Taking ETC(ethical the counter)medicine including oriental medicine within 14 days or taking OTC(over the counter)medicine or vitamin preparations within 7 days
- Continued to be taking caffein(caffein>5cup/day), drinking (alcohol>30g/day) and severe heavy smoker(cigarette>1/2pack/day)
- An impossible one who participates in clinical trial by investigator's decision including for reason laboratory test result
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: SYO-1126
Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
|
Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
Andre navn:
|
Aktiv komparator: Glivec film coated tab 4T(400mg)
100mg/tablet, po, 4 tablets once daily for period I&II D1(crossover)
|
Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pharmacokinetics of the AUCt SYO-1126 anf Glivec Film coated tab 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Pharmacokinetics of the Cmax SYO-1126 anf Glivec Film coated tab 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Pharmacokinetics of the AUCinf SYO-1126 and Glivec Film Coated 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Evaluation of the safety of SYO-1126 and Glivec Film Coated 4T(400mg) from vital signs, physical exam, ECG, laboratory test, adverse events and so on.
Tidsramme: 20~24 days
|
20~24 days
|
Pharmacokinetics of the Tmax of SYO-1126 and Glivec Film Coated 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Pharmacokinetics of the T1/2 of SYO-1126 and Glivec Film Coated 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Pharmacokinetics of the CL/F of SYO-1126 and Glivec Film Coated 4T(400mg)
Tidsramme: 0-72hr
|
0-72hr
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Min Su Park, Doctor, Severance Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SYO1126
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