The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer
- Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics.
- Indication Diabetic kidney disease
Efficacy
Primary
- AUClast, AUCinf, AUClast/D, AUCinf/D
- Cmax, Cmax/D
Secondary
- Tmax, t1/2, CL/F, Vz/F
Safety
- Adverse Event Monitoring
- V/S, EKG, Laboratory Test, P/E
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed.
Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order .
The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs .
One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication .
The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should .
Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second .
Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed.
After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Geonjiro, Deokjin-gu
-
Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Korea, Republikken, 561-712
- Chonbuk National University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- More than 20 years of age at the time of screening and less than 55 years old healthy male
(17.5 ~ 30.5 kg/m2 body mass index (BMI) and weight 45 kg or more
☞ body mass index (BMI) = weight (kg) / height (m) 2
- No congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings
Exclusion Criteria:
- Clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence
- Drugs that may affect the absorption of all the states (eg, gastrectomy)
- Investigational drugs within two months before the first dose participated in other clinical trials
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: A Group
|
DW1029M300mg PO Once
Andre navn:
DW1029M300mg 2 tablets Once
Andre navn:
DW1029M300mg 4 tablets PO Once
Andre navn:
|
|
Eksperimentell: B Group
|
DW1029M300mg PO Once
Andre navn:
DW1029M300mg 2 tablets Once
Andre navn:
DW1029M300mg 4 tablets PO Once
Andre navn:
|
|
Eksperimentell: C Group
|
DW1029M300mg PO Once
Andre navn:
DW1029M300mg 2 tablets Once
Andre navn:
DW1029M300mg 4 tablets PO Once
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum Concentration of DW1029M in plasma
Tidsramme: 24 hours
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area under concentration-time curve of DW1029M in plasma
Tidsramme: 24hours
|
24hours
|
|
Time to maximal concentration of DW1029M in Plasma
Tidsramme: 24hours
|
24hours
|
|
Elimination half time of DW1029M in Plasma
Tidsramme: 24hours
|
24hours
|
|
Apparent clearance of DW1029M in Plasma
Tidsramme: 24hours
|
24hours
|
|
Apparent volume of distribution of DW1029M in Plasma
Tidsramme: 24hours
|
24hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DW1029M-I-3
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