Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: HM30181AK 1mg (Drug); HM30181AK 5mg (Drug); HM30181AK 15mg (Drug); HM30181AK 60mg (Drug); Loperamide 2mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hanmi Pharmaceutical Company Limited Official(s) and/or principal investigator(s): Kyung-Sang Yu, MD., Ph.D, Principal Investigator, Affiliation: Seoul National University Hospital
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.
Clinical Details
Official title: Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.
Secondary outcome: Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Healthy male volunteers aged 20 to 50 years at screening
2. 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
3. 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 Criteria:
1. Subjects who have the clinically significant diseases or history in liver, kidney,
nervous system, respiratory system, endocrine system, blood tumor and cardiovascular
system.
2. 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).
3. The following results in laboratory test
- AST, ALT > 1. 25 x upper limits of normal
4. Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure
below 65 mmHg or above 95 mmHg in vital signs
5. History of drug allergy or other allergies which are clinically significant
6. History of drug abuse or positive reaction for drug abuse in urine screening test
7. 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.)
8. Subjects who have participated in other clinical trial within 2 months prior to the
first day of drug administration
9. 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
10. Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit
drinking during clinical trial period
11. Subject who are smoking over 10 cigar/day
12. Subjects who eat food containing caffeine or grapefruit or drink alcohol in
prohibited period
13. Subjects who are inappropriate in the judgement of the investigator due to the
reasons including clinical laboratory test results
Locations and Contacts
Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: June 2009
Last updated: September 10, 2010
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