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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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 .
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Geonjiro, Deokjin-gu
-
Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Korea, Republiken av, 561-712
- Chonbuk National University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: A Group
|
DW1029M300mg PO Once
Andra namn:
DW1029M300mg 2 tablets Once
Andra namn:
DW1029M300mg 4 tablets PO Once
Andra namn:
|
|
Experimentell: B Group
|
DW1029M300mg PO Once
Andra namn:
DW1029M300mg 2 tablets Once
Andra namn:
DW1029M300mg 4 tablets PO Once
Andra namn:
|
|
Experimentell: C Group
|
DW1029M300mg PO Once
Andra namn:
DW1029M300mg 2 tablets Once
Andra namn:
DW1029M300mg 4 tablets PO Once
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum Concentration of DW1029M in plasma
Tidsram: 24 hours
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Area under concentration-time curve of DW1029M in plasma
Tidsram: 24hours
|
24hours
|
|
Time to maximal concentration of DW1029M in Plasma
Tidsram: 24hours
|
24hours
|
|
Elimination half time of DW1029M in Plasma
Tidsram: 24hours
|
24hours
|
|
Apparent clearance of DW1029M in Plasma
Tidsram: 24hours
|
24hours
|
|
Apparent volume of distribution of DW1029M in Plasma
Tidsram: 24hours
|
24hours
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DW1029M-I-3
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