Clinical trial to investigate the extent of P-glycoprotein inhibition after oral administration of HM30181A in healthy male subjects: An open, single sequence, 4-period crossover within dose group, parallel dose group desig

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0000983
• Lead Sponsor: Hanmi Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

1) healthy male at the age of 20-50
2) body weight >=50kg and within 20% of ideal body weight

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 < 100 mmHg or > 150 mmHg, or diastolic blood pressure < 65 mmHg or > 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
loperamide area under the concentration curve (AUC);pupil diameter change

Secondary Outcome Measures

Name	Time	Method
Alertness using Visual analogue scale(VAS);Oxygen saturation