None listed
Conditions
Interventions
Drug : The subjects were received a single dose of fixed-dose combination of pitavastatin/valsartan 4/160 mg as the test drug, or a loose combination of 2 tablets of pitavastatin 2 mg and 1 tablet of
Sponsors
JW Pharmaceutical Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy male volunteers, aged between 20 and 45 years old, with body mass index (BMI) range of 19 to 26 kg/? 2.Subjects who are able to collect blood sample during study and able to follow-up visit 3.Subjects with vital sign of the following range in sitting. 90=Systolic blood pressure(SBP<145(mmHg) 60=Diastolic blood pressure(DBP)<90(mmHg) 45=Pulse rate=95 (/min) 4.Subjects with blood pressure of the following range in the screening test. - Blood pressure: 90=Systolic blood pressure(SBP<145(mmHg), 60=Diastolic blood pressure(DBP)<90(mmHg) - 45=Pulse rate=95 (/min) 5.Subjects who are informed of this study, and voluntarily agree to participate in this study and signs informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who have a clinically significant past or present medical history of hepato, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, psychiatric, hematologic/neoplastic, and cardiovascular diseases 2.Subjects with a history of gastrointestinal disease (e.g. Crone’s disease, ulceration, acute or chronic pancreatitis, etc) or surgery (except simple appendectomy, repair of a hernia), which can influence the absorption of the study drug. 3.Subjects with hypersensitivity reactions to drugs like pitavastatin, valsartan or other drug (aspirin, antibiotics, etc.) 4.Subjects who have a history of drug abuse or who were positive for the abused drug on urine drug screening 5.Subject who used herbal remedies within 30 days prior to the scheduled 1st study drug administration, who used ethical-the-counter drugs within 14 days prior to the scheduled 1st study drug administration and who used over-the-counter drugs within 7 days prior to the scheduled 1st study drug administration (But, subject whose other conditions are judged by investigators as appropriate for this clinical trial could participate in this study.) 6.Subject who took Unusual eating(e.g. grapefruit juice (more than 1 L per day) which can influence the absorption, distribution, metabolism, and clearance of the study drug within 14 days prior to the scheduled 1st study drug administration 7.Subjects who has participated in any other clinical trial either for investigational or marketed drugs within 90 days prior to the scheduled 1st study drug administration 8.Subjects who have donated whole blood within 60 days or any blood products within 30 days prior to the scheduled 1st study drug administration. Also, subjects who receive a blood transfusion within 30 days prior to the scheduled 1st study drug administration 9.Subject who took barbiturates or an inducer or inhibitor of drug metabolite enzymes within 30 days before the first study drug administration 10.Subjects who excessively drink alcohol or caffeine-containing products or excessively smoke a tobacco products within 3 months prior to the scheduled 1st administration or with a history of alcoholism (caffeine-containing products > 5 units/day, alcohol 21 units/week (1 unit=10 mL as pure alcohol), tobacco products > 10 unit/day) 11.Subjects who are positive result of RPR Ab, anti HIV(AIDS), HBs Ag and HCV Ab 12.Subjects who are creatinine clearance with Cockroft-Gault = 80 mL/min 13.Subjects who with a history of hereditary muscle disorders or family history, or those with a history of muscle disorders caused by drugs 14.Subjects who were judged by investigator (or Sub-Investigator) as inappropriate for the clinical trial for abnormality of clinical laboratory examination, electrocardiogram (ECG), and etc. (AST(GOT), ALT(GPT), Total Bilirubin > Upper reference range limit x 1.5) 15.Subjects who are scheduled for dental procedure(extraction of a tooth, tooth correction, endodontic treatment, etc.) and elective operation (cosmetic plastic surgery, LASIK(Laser-Assisted In-Situ Keratomileusis), LASEK (Laser-Assisted Sub-Epithelial Keratectomy), etc) until post-study visit after informed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0-last measurable time point area under mean plasma concentration-time curve;Maximal plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 0-infinity area under mean plasma concentration-time curve;Half-life;Time for the maximal plasma concentration | — |
Countries
Korea, Republic of
Contacts
Public ContactKim Hoon
Chungnam National University Hospital
Outcome results
None listed