A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
|ClinicalTrials.gov Identifier: NCT01762397|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : May 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastritis Gastric Ulcer||Drug: PMK-S005||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2013|
|Experimental: PMK-S005||Drug: PMK-S005|
- Safety [ Time Frame: 8day ]
- 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 ]
- Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.
- Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762397
|Korea, Republic of|
|Chungnam national university hospital|
|Daejeon, Chungnam, Korea, Republic of, 301-721|