None listed
Conditions
Interventions
Drug : - Treatment A : Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
- Treatment B : GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three
Sponsors
GL PharmTech
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) 19~ 45 aged healthy adult male (2) Body weight at least 45kg and BMI(body mass index) within the range of 17.5 to 30.5kg/m2 (3) Do not have any disease or symptoms which is clinically significant (4) Acceptable physical examination and clinical examination, during screening (5) Provision of signed written informed consent
Exclusion criteria
Exclusion criteria: (1) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) (2) A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug (3) History of regular alcohol consumption exceeding 210g/week (1 drink (250mL) = 10g of beer (5%), 1 drink (50mL) = 8g of hard liquor (20%), 1 drink (125mL) = 12g of wine (12%)) within 6 months of Screening. (4) Participation in clinical trials of any drug within 60 days prior to the participation of the study (5) Systolic BP =140 mmHg or Diastolic BP =90 mmHg (6) someone who has a history of drug abuse or misuse (7) IP first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 30 days (8) Use of tobacco in excess of the equivalent of 5 cigarettes per day (9) someone who has taken other ETC drugs or OTC drugs within the last 10 days or 5 half lives(whichever is longer) (10) Blood donation during 2 months or apheresis during 1 month before the study (11) Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol (12) someone who can't take a meal derived from this trial (13) someone who has taken abnormal meals like which can affect to drug ADME (14) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study (15) Allergy or intolerance to one of the study medications (16) ????? ???(galactose intolerance), Lapp ?????? ???(Lapp lactose deficiency) someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (17) Judged to be inappropriate for the study by the investigator after reviewing other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Css,max of Pregabalin;AUCt(0~24) of Pregabalin | — |
Secondary
| Measure | Time frame |
|---|---|
| Css,min of Pregabalin;Css,ave of Pregabalin;Tmax of Pregabalin;T1/2 of Pregabalin;CL/F of Pregabalin;Vd/F of Pregabalin;Degree of fluctuation of Pregabalin;Swing of Pregabalin;R of Pregabalin | — |
Countries
Korea, Republic of
Contacts
Public ContactMin-Gul Kim
Chonbuk National University Hospital
Outcome results
None listed