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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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-
Geonjiro, Deokjin-gu
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Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Korea, republiek van, 561-712
- Chonbuk National University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: A Group
|
DW1029M300mg PO Once
Andere namen:
DW1029M300mg 2 tablets Once
Andere namen:
DW1029M300mg 4 tablets PO Once
Andere namen:
|
|
Experimenteel: B Group
|
DW1029M300mg PO Once
Andere namen:
DW1029M300mg 2 tablets Once
Andere namen:
DW1029M300mg 4 tablets PO Once
Andere namen:
|
|
Experimenteel: C Group
|
DW1029M300mg PO Once
Andere namen:
DW1029M300mg 2 tablets Once
Andere namen:
DW1029M300mg 4 tablets PO Once
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Maximum Concentration of DW1029M in plasma
Tijdsspanne: 24 hours
|
24 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Area under concentration-time curve of DW1029M in plasma
Tijdsspanne: 24hours
|
24hours
|
|
Time to maximal concentration of DW1029M in Plasma
Tijdsspanne: 24hours
|
24hours
|
|
Elimination half time of DW1029M in Plasma
Tijdsspanne: 24hours
|
24hours
|
|
Apparent clearance of DW1029M in Plasma
Tijdsspanne: 24hours
|
24hours
|
|
Apparent volume of distribution of DW1029M in Plasma
Tijdsspanne: 24hours
|
24hours
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DW1029M-I-3
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