Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet (PGP inhibitor)
This study has been completed.
Sponsor:
Hanmi Pharmaceutical Company Limited
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00954304
First received: August 6, 2009
Last updated: September 10, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: HM30181AK 1mg Drug: HM30181AK 5mg Drug: HM30181AK 15mg Drug: HM30181AK 60mg Drug: Loperamide 2mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hanmi Pharmaceutical Company Limited:
Primary Outcome Measures:
- Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement. [ Time Frame: Day 1~Day 18 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1mg group
Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
|
Drug: HM30181AK 1mg
HM30181AK 1mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
|
|
Experimental: 5mg group
Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15
|
Drug: HM30181AK 5mg
HM30181AK 5mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
|
|
Experimental: 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
|
Drug: HM30181AK 5mg
HM30181AK 5mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
|
|
Experimental: 15mg group
Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
|
Drug: HM30181AK 15mg
HM30181AK 15mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
|
|
Experimental: 60mg group
Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
|
Drug: HM30181AK 60mg
HM30181AK 60mg tablet
Drug: Loperamide 2mg
Loperamide 2mg capsule
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954304
Locations
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
| Principal Investigator: | Kyung-Sang Yu, MD., Ph.D | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Kyung-mi Park/ Director, Hanmi Pharmaceutical Company Limited |
| ClinicalTrials.gov Identifier: | NCT00954304 History of Changes |
| Other Study ID Numbers: | HM-OXL-104 |
| Study First Received: | August 6, 2009 |
| Last Updated: | September 10, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Hanmi Pharmaceutical Company Limited:
|
Pgp inhibitor P-glycoprotein inhibitor |
Additional relevant MeSH terms:
|
Krestin Loperamide Antidiarrheals Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents |
Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Interferon Inducers Radiation-Protective Agents Protective Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013