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

Healthy Male Subjects Clinical Trial

— AGSPT_PD  

Official title:

A Block-randomized, Open-Label, Multiple Oral Dosing, Phase I Study to Explore Comparability of the Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01882296
• Other study ID #: AGSPT_PD
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 18, 2013
• Last updated: June 19, 2013

Study information

• Verified date: May 2013
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: September 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 ~ 26 kg/m2

• Blood Pressure : "140 mmHg = sitting SBP = 90 mmHg, 95 mmHg = sitting DBP = 50 mmHg"

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• AGSPT_10
AGSPT 10mg for 7days administration
• AGSPT_20
AGSPT 20mg for 7days administration
• AGSPT_40
AGSPT 20mg x 2tablet for 7days administration
• Pantoprazole_20
Pantoprazole 20mg for 7days administration
• Pantoprazole_40
Pantoprazole 40mg for 7days administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24h pH		24 hours	No
Secondary	%Time pH>6	(Time(hour) percent when pH >6) / 24(hours)	24 hours	No
Secondary	% inhibition time gastric pH=4	100-(percent time pH >4)	24 hours	No