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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 .
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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-
Geonjiro, Deokjin-gu
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Jeonju-si, Jeollabuk-do, Geonjiro, Deokjin-gu, Corée, République de, 561-712
- Chonbuk National University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: A Group
|
DW1029M300mg PO Once
Autres noms:
DW1029M300mg 2 tablets Once
Autres noms:
DW1029M300mg 4 tablets PO Once
Autres noms:
|
|
Expérimental: B Group
|
DW1029M300mg PO Once
Autres noms:
DW1029M300mg 2 tablets Once
Autres noms:
DW1029M300mg 4 tablets PO Once
Autres noms:
|
|
Expérimental: C Group
|
DW1029M300mg PO Once
Autres noms:
DW1029M300mg 2 tablets Once
Autres noms:
DW1029M300mg 4 tablets PO Once
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Maximum Concentration of DW1029M in plasma
Délai: 24 hours
|
24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Area under concentration-time curve of DW1029M in plasma
Délai: 24hours
|
24hours
|
|
Time to maximal concentration of DW1029M in Plasma
Délai: 24hours
|
24hours
|
|
Elimination half time of DW1029M in Plasma
Délai: 24hours
|
24hours
|
|
Apparent clearance of DW1029M in Plasma
Délai: 24hours
|
24hours
|
|
Apparent volume of distribution of DW1029M in Plasma
Délai: 24hours
|
24hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Cheol-hee Lim, CR Manager, DongWha Pharmaceutical Company
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DW1029M-I-3
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