- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00960453
Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin
Multiple-dose, Dose Escalation Study to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin in Healthy Male Volunteers
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 110-744
- Clinical Trials Center; Seoul National University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy male subjects aged 20 - 50 years
- A body mass index (BMI) in the range 17-28 kg/m2
- Fasting plasma glucose levels in the range 70-110 mg/dL
- Sufficient ability to understand the nature of the study and any hazards of participating in it
- Provide written informed consent after being fully informed about the study procedures
Exclusion Criteria:
- Presence or history of severe adverse reaction to any drug (e.g., sitagliptin) or a history of severe allergic disease
- Clinically relevant abnormal medical history that could interfere with the objectives of the study
- A subject who has the following screening laboratory test results; creatinine clearance (calculated by Cockcroft-Gault equation) < 80 mL/min
- History of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A subject whose SBP is over 150 mmHg or below 100 mmHg and DBP is over 95 mmHg or below 65 mmHg
- Presence or history of drug abuse
- Participation in other clinical trial within 2 months
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose
- Blood donation during 2 months or apheresis during 1 month before the study
- Presence or history of alcohol abuse
- Users of nicotine-containing substances within the previous three months
- Use of grapefruit juice, alcohol or smoking during restriction period
- Subject judged not eligible for study participation by investigator
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Sitagliptin 25mg
Repeated administrations for 4 days
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Dosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods |
Annen: Sitagliptin 50mg
Repeated administrations for 4 days
|
Dosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods |
Annen: Sitagliptin 100mg
Repeated administrations for 4 days
|
Dosage form: 25mg, 50mg ,100mg Amount: 25mg, 50mg, 100mg Frequency and duration: once a day, for 4 days, including 5 days washout periods |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the pharmacokinetics after repeated administrations of sitagliptin 25, 50 and 100 mg
Tidsramme: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
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Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
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To evaluate the pharmacodynamics (activity of Dipeptidyl peptidase-IV enzyme) after repeated administrations of sitagliptin 25, 50 and 100 mg
Tidsramme: Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours after drug administration
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Kyung-Sang Yu, MD, PhD, Seoul National University College of Medicine and Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SNUCPT09_Sitagliptin
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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