Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
NCT ID: NCT00954304
Last Updated: 2010-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-06-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1mg group
Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
HM30181AK 1mg
HM30181AK 1mg tablet
Loperamide 2mg
Loperamide 2mg capsule
5mg group
Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15
HM30181AK 5mg
HM30181AK 5mg tablet
Loperamide 2mg
Loperamide 2mg capsule
10mg group
Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
HM30181AK 5mg
HM30181AK 5mg tablet
Loperamide 2mg
Loperamide 2mg capsule
15mg group
Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
HM30181AK 15mg
HM30181AK 15mg tablet
Loperamide 2mg
Loperamide 2mg capsule
60mg group
Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
HM30181AK 60mg
HM30181AK 60mg tablet
Loperamide 2mg
Loperamide 2mg capsule
Interventions
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HM30181AK 1mg
HM30181AK 1mg tablet
HM30181AK 5mg
HM30181AK 5mg tablet
HM30181AK 15mg
HM30181AK 15mg tablet
HM30181AK 60mg
HM30181AK 60mg tablet
Loperamide 2mg
Loperamide 2mg capsule
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
50 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Hanmi Pharmaceutical Company Limited
Principal Investigators
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Kyung-Sang Yu, MD., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-OXL-104
Identifier Type: -
Identifier Source: org_study_id