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

NCT01882296 | Unknown Phase 1 DMC

• 1 other identifier: AGSPT_PD
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (1)

• 24h pH

  24 hours

Secondary Outcomes (2)

• %Time pH>6

  24 hours

• % inhibition time gastric pH≤4

  24 hours

Study Arms (5)

AGSPT_10

EXPERIMENTAL

tablet, 10mg, QD, 7days

Drug: AGSPT_10

AGSPT_20

EXPERIMENTAL

tablet, 20mg, QD, 7days

Drug: AGSPT_20

AGSPT_40

EXPERIMENTAL

tablet, 20mg x 2, QD, 7days

Drug: AGSPT_40

Pantoprazole_20

ACTIVE COMPARATOR

tablet, 20mg, QD, 7days

Drug: Pantoprazole_20

Pantoprazole_40

ACTIVE COMPARATOR

tablet, 40mg, QD, 7days

Drug: Pantoprazole_40

Interventions

AGSPT_10 DRUG

AGSPT 10mg for 7days administration

AGSPT_10

AGSPT_20 DRUG

AGSPT 20mg for 7days administration

AGSPT_20

AGSPT_40 DRUG

AGSPT 20mg x 2tablet for 7days administration

AGSPT_40

Pantoprazole_20 DRUG

Pantoprazole 20mg for 7days administration

Pantoprazole_20

Pantoprazole_40 DRUG

Pantoprazole 40mg for 7days administration

Pantoprazole_40

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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"

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 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

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Primary Completion: September 1, 2013
• Last Updated: June 20, 2013

Record last verified: 2013-05