prevent and lower internal exposure of thyroid caused by radioiodine.
Conditions
Interventions
NIG-0392
Potassium iodine
Non-administration (no medicine, water only)
Sponsors
Nichi-Iko Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male subjects between the ages of 20 to 40 years when at informed consent. 2) Body weight between 50 and 80 kg 3) Body Mass Index between 18.5 to 25.0 kg/m2 4) 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. 5) 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) Tuberculosis patient 3) Hyperthyroid patient 4) Hypothyroid patient 5) Renal dysfunction 6) Myotonia congenita 7) Hyperkalemia 8) Subjects who have history of hypocomplementemic urticarial vasculitis 9) Subjects who have history of hypersensitivity for iodine contrast agent 10) Subjects who have history of dermatitis herpetiformis Duhring 11) Subjects who take upper gastrointestinal endoscopy in the term from screening test to one week after administration. 12) Serological reaction of syphilis, HBsAg, HCVAb or HIVAb positive 13) 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) 14) Subjects who have present or past history of cardiovascular system, immune system, hematologic, brain vasculature, respiratory system, digestive system, liver or renal disease 15) History of gastrointestinal tract surgery which has an effect on the drug absorption such as gastrectomy, gastrointestinal suture, or intestinal resection 16) Presence of alcohol or drug dependency 17) Subjects who need some cure for actual allergic symptom, such as asthma, pollinosis, or atopic dermatitis 18) Subjects who use other medicine in the week prior to hospitalization of 1st period or need to take other medicine during the test (including external preparation etc.) 19) Enrolled in another investigational study and took other investigational drug within 4 months(if it is a patch test, within one month) 20) 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. 21) Subjects who are judged ineligible for entry to this study by the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma iodine concentration safety | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary iodine concentration | — |
Countries
Japan
Contacts
Public ContactTakuro Yamashiro
Nichi-Iko Pharmaceutical Co., Ltd. Dept. of Clinical Study
Outcome results
None listed