Healthy Male SubjectsPhase 1AGSPT_PDNCT01882296
Investigate a Pharmacodynamics Between S-pantoprazole 10, 20, 40mg and Pantoprazole 20, 40mg in Healthy Male Subjects
A Phase 1 study testing AGSPT_10, AGSPT_20 and AGSPT_40 in people with Healthy Male Subjects, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- AGSPT_10, AGSPT_20 and AGSPT_40
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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"
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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
- Being tested
- AGSPT_10, AGSPT_20, AGSPT_40, Pantoprazole_20, Pantoprazole_40
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGSPT_10Drug
AGSPT 10mg for 7days administration
AGSPT_20Drug
AGSPT 20mg for 7days administration
AGSPT_40Drug
AGSPT 20mg x 2tablet for 7days administration
Pantoprazole_20Drug
Pantoprazole 20mg for 7days administration
Pantoprazole_40Drug
Pantoprazole 40mg for 7days administration
| Study group | Role | What they receive |
|---|---|---|
| AGSPT_10 | Experimental | tablet, 10mg, QD, 7days Receives: Drug: AGSPT_10 |
| AGSPT_20 | Experimental | tablet, 20mg, QD, 7days Receives: Drug: AGSPT_20 |
| AGSPT_40 | Experimental | tablet, 20mg x 2, QD, 7days Receives: Drug: AGSPT_40 |
| Pantoprazole_20 | Active comparator | tablet, 20mg, QD, 7days Receives: Drug: Pantoprazole_20 |
| Pantoprazole_40 | Active comparator | tablet, 40mg, QD, 7days Receives: Drug: Pantoprazole_40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h pH
Measured: 24 hours
Secondary outcomes (2)
%Time pH>6
(Time(hour) percent when pH >6) / 24(hours)
Measured: 24 hours
% inhibition time gastric pH≤4
100-(percent time pH >4)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882296
- Sponsor's protocol ID
- AGSPT_PD
- Acronym
- AGSPT_PD
- Status last verified
- May 2013
- First submitted
- 18 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01882296
- Acronym / sponsor ID
- AGSPT_PD / AGSPT_PD
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Primary completion
- Sep 2013 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AGSPT_10 | Experimental | Drug: AGSPT_10tablet, 10mg, QD, 7days |
| AGSPT_20 | Experimental | Drug: AGSPT_20tablet, 20mg, QD, 7days |
| AGSPT_40 | Experimental | Drug: AGSPT_40tablet, 20mg x 2, QD, 7days |
| Pantoprazole_20 | Active comparator | Drug: Pantoprazole_20tablet, 20mg, QD, 7days |
| Pantoprazole_40 | Active comparator | Drug: Pantoprazole_40tablet, 40mg, QD, 7days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGSPT_10AGSPT 10mg for 7days administration | Drug | AGSPT_10 |
| AGSPT_20AGSPT 20mg for 7days administration | Drug | AGSPT_20 |
| AGSPT_40AGSPT 20mg x 2tablet for 7days administration | Drug | AGSPT_40 |
| Pantoprazole_20Pantoprazole 20mg for 7days administration | Drug | Pantoprazole_20 |
| Pantoprazole_40Pantoprazole 40mg for 7days administration | Drug | Pantoprazole_40 |
Primary outcome
24h pH
Time frame: 24 hours
2 secondary outcomes
%Time pH>6
Time frame: 24 hours
% inhibition time gastric pH≤4
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGSPT_10, AGSPT_20 and AGSPT_40 in people with Healthy Male Subjects, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h pH (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.