Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
14. januar 2018 oppdatert av: Hanmi Pharmaceutical Company Limited
A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers
This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy Male Volunteers
Studieoversikt
Detaljert beskrivelse
This study is a 2-part study, where in Part A, the 40 mg dose will be performed followed by the 20 mg dose in Part B.
Studietype
Intervensjonell
Registrering (Forventet)
96
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Seoul, Korea, Republikken
- Seoul National University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Age 19~50 years in healthy male volunteers
- BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria:
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Sequence Group 1
Period 1: Reference Drug(HGP1705) Period 2: Test Drug(HIP1601)
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Test Drug
Andre navn:
Reference Drug
Andre navn:
|
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Eksperimentell: Sequence Group 2
Period 1: Test Drug(HIP1601) Period 2: Reference Drug(HGP1705)
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Test Drug
Andre navn:
Reference Drug
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUClast of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
|
After 7days of repeated administration, Total gastric acidity decrease rate versus baseline for 24 hours
Tidsramme: 7Day 24h(Full time) pH monitoring
|
pharmacodynamic evaluation
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7Day 24h(Full time) pH monitoring
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUCinf of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
|
Cmax of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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Tmax of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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Terminal Half-life of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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CL/F of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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Vd/F of esomeprazole
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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Ctrough
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 51 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 2 Day 0 hour
|
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Ctrough,ss
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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PTF
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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RActrough
Tidsramme: 1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
pharmacokinetic evaluation
|
1 Day 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 4 Day 0 hour, 5 Day 0 hour, 6 Day 0 hour, 7 Day 0 hour, 8 Day 0 hour
|
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After the first administration of esomeprazole, The rate of decrease of integrated gastric acidity compared to baseline for 24 hours
Tidsramme: 1Day 24h pH monitoring
|
pharmacodynamic evaluation
|
1Day 24h pH monitoring
|
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After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Tidsramme: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
|
pharmacodynamic evaluation
|
1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
|
|
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Tidsramme: 1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
|
pharmacodynamic evaluation
|
1Day(Full time) pH monitoring, 7Day 24h(Full time) pH monitoring
|
|
After first administration and 7 days of repeated administration, Total gastric acidity reduction rate versus baseline between 12hours and 24 hours
Tidsramme: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
|
pharmacodynamic evaluation
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1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
|
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After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher between 12hours and 24 hours
Tidsramme: 1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
|
pharmacodynamic evaluation
|
1Day 12h, 2Day 0h, 7Day 12h, 8Day 0h
|
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After the first dose and 7 days of repeated dosing, The median pH measured between 12hours and 24 hours
Tidsramme: 1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring
|
pharmacodynamic evaluation
|
1Day (12~24h) pH monitoring, 7Day (12~24h) pH monitoring
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
After first administration and repeated administration for 7 days, The percentage of decrease in integrated gastric acidity compared to baseline by time
Tidsramme: 1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring
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exploratory endpoint
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1Day(Full time) pH monitoring, 7Day 24h (Full time) pH monitoring
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Forventet)
15. februar 2018
Primær fullføring (Forventet)
15. juni 2018
Studiet fullført (Forventet)
15. juni 2018
Datoer for studieregistrering
Først innsendt
8. desember 2017
Først innsendt som oppfylte QC-kriteriene
11. desember 2017
Først lagt ut (Faktiske)
14. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HM-ESOM-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Nei
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Nei
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