Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
S-Pantoprazole
A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects
1 other identifier
interventional
44
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedApril 1, 2013
March 1, 2013
2 months
March 25, 2013
March 29, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
AUClast
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Secondary Outcomes (3)
AUCinf
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Tmax
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
T1/2β
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours
Study Arms (2)
AGSPT_L20
EXPERIMENTALtablet, q.d.
Pantoloc 40mg
ACTIVE COMPARATORtablet, q.d.
Interventions
Eligibility Criteria
You may qualify if:
- Adult healthy males 20 to 45 years at screening.
- BMI : 19kg/m2 \~ 26kg/m2
- Blood Pressure : "140 \> sitting SBP ≥ 90mmHg, 90 \> sitting DBP ≥ 60mmHg"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
April 1, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2013
Last Updated
April 1, 2013
Record last verified: 2013-03