HealthyPhase 1NCT01332890
Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
A Phase 1 study testing Sequence 1, Sequence 2 and Sequence 3 in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
To evaluate drug-drug interaction Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sequence 1, Sequence 2 and Sequence 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Aug 2011
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
- Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- Eligible for blood sampling during study period
- Provision of signed written informed consent
Who cannot join
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Clinically significant illness or within 30days before the first dose
- Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
- Use of prescribed medication during the 14 days before administration of the first dose of investigational product
- Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product
Show all 9Show fewer
- Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days
- Consuming more than 21 units of alcohol per week
- Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
To evaluate drug-drug interaction
Read the detailed description
The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects
- Conditions
- Healthy
- Being tested
- Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5
- Keywords
- Drug interaction, revaprazan, Itopride HCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence 1Other
Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Sequence 2Other
Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Sequence 3Other
Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Sequence 4Other
Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Sequence 5Other
Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Sequence 6Other
Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Other: Sequence 1 |
| Sequence 2 | Experimental | Not described Receives: Other: Sequence 2 |
| Sequence 3 | Experimental | Not described Receives: Other: Sequence 3 |
| Sequence 4 | Experimental | Not described Receives: Other: Sequence 4 |
| Sequence 5 | Experimental | Not described Receives: Other: Sequence 5 |
| Sequence 6 | Experimental | Not described Receives: Other: Sequence 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.
Measured: Blood sampling will be obtained on day 7 at each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332890
- Sponsor's protocol ID
- YCD192
- Status last verified
- Jul 2014
- First submitted
- 7 Apr 2011
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01332890
- Acronym / sponsor ID
- YCD192
- Conditions
- Healthy
- Keywords
- Drug interaction, revaprazan, Itopride HCI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Apr 2011 (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.
To evaluate drug-drug interaction
Detailed description
The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Other: Sequence 1 |
| Sequence 2 | Experimental | Other: Sequence 2 |
| Sequence 3 | Experimental | Other: Sequence 3 |
| Sequence 4 | Experimental | Other: Sequence 4 |
| Sequence 5 | Experimental | Other: Sequence 5 |
| Sequence 6 | Experimental | Other: Sequence 6 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
- Acceptable medical history, physical exam,laboratory tests and EKG, during screening
- Eligible for blood sampling during study period
- Provision of signed written informed consent
Key exclusion criteria (9 listed)
- History of any clinically significant disease
- History of drug/chemical/alcohol abuse
- Clinically significant illness or within 30days before the first dose
- Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
- Use of prescribed medication during the 14 days before administration of the first dose of investigational product
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 |
|---|---|---|
| Sequence 1Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 1 |
| Sequence 2Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 2 |
| Sequence 3Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 3 |
| Sequence 4Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 4 |
| Sequence 5Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 5 |
| Sequence 6Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days) | Other | Sequence 6 |
Primary outcome
Pharmacokinetics
Time frame: Blood sampling will be obtained on day 7 at each period.
Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sequence 1, Sequence 2 and Sequence 3 in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics (time frame: Blood sampling will be obtained on day 7 at each period.). 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 10 Jul 2014.