None listed
Conditions
Interventions
Drug : There are two arms for this study. Sustained release group(once a day) and immediate release group (twice a day). they get drugs for 3 days.
Sponsors
Ildong pharmaceutical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 20~45 aged healthy adult. someone tho has at least 50kg body weight and ideal body weight ±20%
Exclusion criteria
Exclusion criteria: someone has acute symptom at screening phase someone has any disease or symptoms which is clinically significant someone had been determined during healthy examination in screening period AST or ALT > 1.5 times than normal Total bilirubin > 1.5 times than normal someone who has a history of allergy, anaphylaxis, drug abuse or misuse. someone who had enrolled to other clinical trial within the last 60 days. someone who had donated blood within the last 60 days. someone who can't take a meal derived from this trial. someone who has taken abnormal meals like which can affect to drug Absorbtion, Distribution, Metabolism, Excretion someone who has taken other prescription medicine or oriental drugs within the last 14 days, Or over-the-counter drugs within the last 7 days someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before. someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day. someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure blood concentration of pregabalin | — |
Secondary
| Measure | Time frame |
|---|---|
| safety evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactDongsuk Lim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed