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Completed

NCT Number: NCT00954304

Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM30181AK 1mg

Drug

HM30181AK 1mg tablet

HM30181AK 5mg

Drug

HM30181AK 5mg tablet

HM30181AK 15mg

Drug

HM30181AK 15mg tablet

HM30181AK 60mg

Drug

HM30181AK 60mg tablet

Loperamide 2mg

Drug

Loperamide 2mg capsule

Primary outcomes

  1. Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.

    Time frame: Day 1~Day 18

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Acronym: PGP inhibitor

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2009
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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