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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: AGSPT_L20; Drug: Pantoloc 40mg

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sang-Young Yoon; Phone Number: +82-2-3289-4257; Email: agcntechpp@ahn-gook.com
• Study Contact Backup: Name: Cheul-Hun Seong; Phone Number: +82-2-3289-4284; Email: agcntechpp@ahn-gook.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center
    • Principal Investigator: Kyun-Seop Bae, M.D., Ph.D.
    • Contact: Cheul-Hun Seong; Phone Number: +82-2-3289-4284

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGSPT_L20; tablet, q.d.	Drug: AGSPT_L20
Active Comparator: Pantoloc 40mg; tablet, q.d.	Drug: Pantoloc 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 1, 2013

Study Record Updates

• Last Update Posted (Estimate): April 1, 2013
• Last Update Submitted That Met QC Criteria: March 29, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: AGSPT_L20PK