A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers|
- Safety [ Time Frame: 8day ] [ Designated as safety issue: No ]
- Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
- Before and after physical examination
- Before and after bital Sign: blood pressure, pulse rate, temperature.
- Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec.
- Lab: hematologic examination, blood coagulation examination,urine examination
- Pharmacokinetics [ Time Frame: 8day ] [ Designated as safety issue: No ]
- Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.
- Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
|Study Start Date:||December 2012|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762397
|Korea, Republic of|
|Chungnam national university hospital|
|Daejeon, Chungnam, Korea, Republic of, 301-721|