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

Healthy Male Subjects Clinical Trial

— S-Pantoprazole  

Official title:

A Randomized, Open Label, Single-dose, 2x2 Crossover Study to Investigate a Pharmacokinetics Between S-pantoprazole 20mg and Pantoprazole 40mg in Healthy Male Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01821521
• Other study ID #: AGSPT_L20PK
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 25, 2013
• Last updated: March 29, 2013
• Start date: June 2013

Study information

• Verified date: March 2013
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: Sang-Young Yoon
• Phone: +82-2-3289-4257
• Email: agcntechpp[@]ahn-gook.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• AGSPT_L20

• Pantoloc 40mg

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours	No
Primary	AUClast		0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours	No
Secondary	AUCinf		0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours	No
Secondary	Tmax		0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours	No
Secondary	T1/2ß		0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours	No