CClinicalTrials.gg
Status unknownNCT01882296AGSPT_PDUpdated Jun 20, 2013

Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects

A Phase 1 interventional study of AGSPT_10 and AGSPT_20 in Healthy Male Subjects, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Status unknown. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-20.

Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

Primary object: Evaluate Pharmacodynamic property and safety administered S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in healthy male subjects

Secondary object : Evaluate Dose-response of S-pantoprazole and pantoprazole and compare each dose-response

02

Conditions studied

  • Healthy Male Subjects
03

In context

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 23 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult healthy males 20 to 45 years at screening
  • BMI : 19kg/m2 \~ 26 kg/m2
  • Blood Pressure : "140 mmHg ≥ sitting SBP ≥ 90 mmHg, 95 mmHg ≥ sitting DBP ≥ 50 mmHg"

Exclusion criteria

Exclusion Criteria:

  • Have history of significant hepatic, renal gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
  • Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery (except for Appendectomy, hernia repair) affected the absorption of medications
  • Have history of GERD, Gastric ulcer, Duodenal ulcer and H.pylori positive
  • Hypersensitivity reactions to drugs of clinically significant hypersensitivity reactions in the history of benzimidazole (ex: pantoprazole, NSAID, antibiotic)
  • Have a history of drug abuse
  • unusual diet affected the absorption, distribution, metabolism, excretion of medications
  • Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
  • Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
  • Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
  • Subject who have taken habitually caffeine (caffeine > 5 units/day)
  • Subject who have drunken habitually (alcohol > 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
  • Subjects deemed ineligible by investigator based on other reasons
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    AGSPT_10

    tablet, 10mg, QD, 7days

    Drug: AGSPT_10

  • Experimental
    AGSPT_20

    tablet, 20mg, QD, 7days

    Drug: AGSPT_20

  • Experimental
    AGSPT_40

    tablet, 20mg x 2, QD, 7days

    Drug: AGSPT_40

  • Active comparator
    Pantoprazole_20

    tablet, 20mg, QD, 7days

    Drug: Pantoprazole_20

  • Active comparator
    Pantoprazole_40

    tablet, 40mg, QD, 7days

    Drug: Pantoprazole_40

Interventions

  • DrugAGSPT_10

    AGSPT 10mg for 7days administration

  • DrugAGSPT_20

    AGSPT 20mg for 7days administration

  • DrugAGSPT_40

    AGSPT 20mg x 2tablet for 7days administration

  • DrugPantoprazole_20

    Pantoprazole 20mg for 7days administration

  • DrugPantoprazole_40

    Pantoprazole 40mg for 7days administration

06

What researchers measure

Primary outcomes

  1. 24h pH

    Time frame: 24 hours

Secondary outcomes

  1. %Time pH>6

    (Time(hour) percent when pH \>6) / 24(hours)

    Time frame: 24 hours

  2. % inhibition time gastric pH≤4

    100-(percent time pH \>4)

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01882296
Lead sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Jun 20, 2013
Primary completion
Sep 2013 (estimated)
Last update
Jun 20, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion