CClinicalTrials.gg
Status unknownNCT01821521S-PantoprazoleUpdated Apr 1, 2013

Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

A Phase 1 interventional study of AGSPT_L20 and Pantoloc 40mg in Healthy Male Subjects, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-01.

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

The sponsor has not verified this record recently (last verified Mar 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

Primary object : Evaluate pharmacokinetic property administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects

Secondary object : Evaluate safety administered S-pantoprazole 20mg and Pantoprazole 40mg in healthy male subjects

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 \~ 26kg/m2
  • Blood Pressure : "140 > sitting SBP ≥ 90mmHg, 90 > sitting DBP ≥ 60mmHg"

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
  • Hypersensitivity reactions to drugs or 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
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    AGSPT_L20

    tablet, q.d.

    Drug: AGSPT_L20

  • Active comparator
    Pantoloc 40mg

    tablet, q.d.

    Drug: Pantoloc 40mg

Interventions

  • DrugAGSPT_L20
  • DrugPantoloc 40mg
06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

  2. AUClast

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

Secondary outcomes

  1. AUCinf

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

  2. Tmax

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

  3. T1/2β

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
    • Cheul-Hun Seong · Contact · +82-2-3289-4284
    • Kyun-Seop Bae, M.D., Ph.D. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01821521
Lead sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Apr 1, 2013
Start date
Jun 2013
Primary completion
Aug 2013 (estimated)
Last update
Apr 1, 2013

Study contacts

Sang-Young Yoon
Contact
agcntechpp@ahn-gook.com
+82-2-3289-4257
Cheul-Hun Seong
Contact
agcntechpp@ahn-gook.com
+82-2-3289-4284

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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