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A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

NCT ID: NCT01762397

Last Updated: 2014-05-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.

Detailed Description

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Conditions

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Gastritis Gastric Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PMK-S005

Group Type EXPERIMENTAL

PMK-S005

Intervention Type DRUG

Interventions

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PMK-S005

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male 20 year ≤ age ≤ 40 year.
* Weight ≥ 55kg, IBW ±20%.
* Patients with normal hematology, biochemistry, urinary result.
* Patients who have not congenital or chronic disease.
* Provision of written informed consent voluntarily.

Exclusion Criteria

* Patients having known hypersensitivity to any component of the study drug.
* Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
* Patients with any gastrointestinal disorders.
* Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
* Drug abuser, alcoholic.
* Patients taking ETC medication within 14 days, OTC within 7 days.
* Patients taking other investigational product within 60 days prior to the participation in the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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PharmaKing

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungnam national university hospital

Daejeon, Chungcheongnam-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PMK-S005

Identifier Type: -

Identifier Source: org_study_id