CompletedNCT01762397Updated May 30, 2014

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

A Phase 1 interventional study of PMK-S005 in Gastritis and Gastric Ulcer, sponsored by PharmaKing. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-30.

Sponsored by PharmaKing · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 20 Years to 40 Years
Sex: Male

Study summary

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.

Conditions studied

Gastritis
Gastric Ulcer

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In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's planned enrollment of 37 is below the median of 200 across 113 interventional studies indexed under Gastritis.

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Lead sponsor

PharmaKing is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 37 participants (estimated)

Study arms

Experimental
PMK-S005
Drug: PMK-S005

Interventions

DrugPMK-S005

What researchers measure

Primary outcomes

Safety
1. Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. 2. Before and after physical examination 3. Before and after bital Sign: blood pressure, pulse rate, temperature. 4. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec. 5. Lab: hematologic examination, blood coagulation examination,urine examination
Time frame: 8day
Pharmacokinetics
1. Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2. 2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
Time frame: 8day

Study locations

1 site

Chungnam national university hospital
Daejeon, Chungnam 301-721, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01762397
Lead sponsor: PharmaKing
Responsible party: Sponsor
First posted: Jan 7, 2013
Start date: Dec 2012
Primary completion: May 2013
Last update: May 30, 2014

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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