Status:
COMPLETED
Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.
Eligibility Criteria
Inclusion
- Healthy male volunteers aged 20 to 50 years at screening
- Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight
- Ideal body weight = (height cm - 100) x 0.9
- Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial
Exclusion
- Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
- History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
- The following results in laboratory test
- AST, ALT \> 1.25 x upper limits of normal
- Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
- History of drug allergy or other allergies which are clinically significant
- History of drug abuse or positive reaction for drug abuse in urine screening test
- Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
- Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
- Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
- Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
- Subject who are smoking over 10 cigar/day
- Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
- Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00954304
Start Date
June 1 2009
End Date
September 1 2009
Last Update
September 13 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea