None listed
Conditions
Interventions
Drug : Single oral administration of loperamide alone(period 1), loperamide plus HM30181(period 2), loperamide plus quinidine(period 2), loperamide alone (period 4:to investigate the duration of effe
Sponsors
Hanmi Pharm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) healthy male at the age of 20-50 2) body weight >=50kg and within 20% of ideal body weight
Exclusion criteria
Exclusion criteria: 1) Clinically significant past history in liver, kidney, psychiatry, pulmonary, endocrinology, blood, tumor, circulation system 2) Gastrointestinal disease(e.g. Crohn's sease) which can influence on the absorption of investigational product 3) Opthalmological disease which can influence on the opthalmic exam. 4) Alanine aminotransferase(ALT),alanin aminotransferase(ALT) > 1.25 times of upper normal limit 5) Systolic blood pressure 150 mmHg, or diastolic blood pressure 95 mmHg 6) QTc >450 msec or clinically significant abnormal finding in electrocardiography 7) Drug hypersensitivity history 8) Drug abuse history or positive finding in urine drug screening 9) Administration of priscribing drug or herbal drug within 2 weeks of IP administration, or administration of over the count(OTC) drug or vitamin within 1 weeks of investigational drug administration 10) Participation in other trial within 2 months of investigational administration 11) Whole blood donation within 2 months or component donation within 2 weeks of investigational administration 12) Excessive drinking(>21 units/week) or subject who cannot stop drinking during trial 13) Smoker (ex-smoker who stops smoking 3months before investigational administration can participate) 14) Subject who consumed food containing caffein or grapefruite or drank alcohol during prohibited period 15) Subject who was judged not eligible due to laboratory results and etc. by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| loperamide area under the concentration curve (AUC);pupil diameter change | — |
Secondary
| Measure | Time frame |
|---|---|
| Alertness using Visual analogue scale(VAS);Oxygen saturation | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Eun Kim
Konkuk University Medical Center
Outcome results
None listed