Hypertension
Conditions
Interventions
NIG-2059, washout, EXFORGE Combination Tablets
EXFORGE Combination Tablets, washout, NIG-2059
Sponsors
Nichi-Iko Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male subjects between the ages of 20 and 35 years when at informed consent. 2) Body Mass Index between 18.5 to 25.0 kg/m2. 3) Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during screening. Some of the laboratory values e.g complete blood count etc that is out of the normal or reference range will be carefully considered by the clinical investigator. 4) Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity for any elements involved in all the investigational agents in this study 2) Subjects who have history of hypersensitivity to dihydropyridine compound 3) Diabetic subject given aliskiren 4) Renal artery stenosis, bilaterally or unilaterally after nephrectomy 5) Hyperkalemia 6) Serious renal dysfunction 7) Liver dysfunction, especially biliary liver cirrhosis or cholestasis 8) Cerebrovascular disorders 9) Serological reaction of syphilis, HBsAg, HCVAb or HIVAb positive 10) AST(GOT) or ALT(GPT) more than the reference value by screening or clinical assay before the administration in each term(excluding the case of AST or ALT value within the standard value by reexamination) 11) Subjects who have present or past history of cardiovascular system, immune system, hematologic, brain vasculature, respiratory system, digestive system, liver or renal disease 12) History of gastrointestinal tract surgery which has an affect on the drug absorption such as gastrectomy, gastrointestinal suture, or intestinal resection 13) Presence of alcohol or drug dependency 14) Subjects who need some cure for actual allergic symptom, such as asthma, pollinosis, or atopic dermatitis 15) Subjects who use other medicine in the week prior to administration of 1st period or need to take other medicine during the test (including external preparation etc.) 16) Enrolled in another investigational study and took other investigational drug within 4 months(if it is a patch test, within one month) 17) Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood content within 2 weeks prior to the time of consent. 18) Subjects who are judged ineligible for entry to this study by the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax AUCt | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf Tmax MRT kel | — |
Countries
Japan
Contacts
Public ContactToshiharu Nakane
Nichi-Iko Pharmaceutical Co., Ltd Dept. of Clinical Study
Outcome results
None listed