A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|