Healthy VolunteersPhase 1NCT04150146
To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers
A Phase 1 study testing Rebamipide SR 150mg after high-fat meal and Rebamipide SR 150mg under fasting condition in people with Healthy Volunteers, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Rebamipide SR 150mg after high-fat meal and Rebamipide SR 150mg under fasting condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2019to 24 Jul 2019
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who give consent to voluntary participation by signing the informed consent form
- Healthy adult males aged ≥19 and ≤45 years at screening
- Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0
Who cannot join
- Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
- Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
- Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration
- Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
- Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
- Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
- Smokers who have smoked >10 cigarettes per day within the last 6 months
- Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and (venereal disease research laboratory) VDRL tests
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Bundang, Gyeonggi-do, 13496
About this study
Official title: A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Rebamipide SR 150mg after high-fat meal, Rebamipide SR 150mg under fasting condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide SR 150mg after high-fat mealDrug
Test Drug
Rebamipide SR 150mg under fasting conditionDrug
Reference Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (RT) | Other | [Sequence A (RT) \& Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. Receives: Drug: Rebamipide SR 150mg after high-fat meal; Drug: Rebamipide SR 150mg under fasting condition |
| Sequence B (TR) | Other | [Sequence A (RT) \& Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
• Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. Receives: Drug: Rebamipide SR 150mg after high-fat meal; Drug: Rebamipide SR 150mg under fasting condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration of Rebamipide
Measured: From Period1/ Day1 to Period2/Day9
AUClast of Rebamipide
Area Under the plasma concentration versus time curve last of Rebamipide
Measured: From Period1/ Day1 to Period2/Day9
Secondary outcomes (3)
t1/2 β of Rebamipide
Time taken for half the initial dose of Rebamipide administered to be eliminated from the body
Measured: From Period1/ Day1 to Period2/Day9
Tmax of Rebamipide
Time at which the Cmax of Rebamipide is observed
Measured: From Period1/ Day1 to Period2/Day9
AUCinf of Rebamipide
Area Under the plasma concentration versus time curve inifinite of Rebamipide
Measured: From Period1/ Day1 to Period2/Day9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Jul 2019
- Primary completion14 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150146
- Sponsor's protocol ID
- 037-402-00036
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04150146
- Acronym / sponsor ID
- 037-402-00036
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 14 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 4 Nov 2019 (actual)
- 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.
This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (RT) | Other | Drug: Rebamipide SR 150mg after high-fat meal, Drug: Rebamipide SR 150mg under fasting condition[Sequence A (RT) \& Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. |
| Sequence B (TR) | Other | Drug: Rebamipide SR 150mg after high-fat meal, Drug: Rebamipide SR 150mg under fasting condition[Sequence A (RT) \& Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who give consent to voluntary participation by signing the informed consent form
- Healthy adult males aged ≥19 and ≤45 years at screening
- Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0
Key exclusion criteria (8 listed)
- Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
- Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
- Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration
- Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
- Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
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 |
|---|---|---|
| Rebamipide SR 150mg after high-fat mealTest Drug | Drug | Sequence A (RT), Sequence B (TR) |
| Rebamipide SR 150mg under fasting conditionReference Drug | Drug | Sequence A (RT), Sequence B (TR) |
Primary outcome
Cmax
Time frame: From Period1/ Day1 to Period2/Day9
Peak Plasma Concentration of Rebamipide
AUClast of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
Area Under the plasma concentration versus time curve last of Rebamipide
3 secondary outcomes
t1/2 β of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
Tmax of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
AUCinf of Rebamipide
Time frame: From Period1/ Day1 to Period2/Day9
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 4 Nov 2019.
- Individual participant dataSharing planned: No
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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 Rebamipide SR 150mg after high-fat meal and Rebamipide SR 150mg under fasting condition in people with Healthy Volunteers, run by Korea Otsuka Pharmaceutical Co., Ltd. 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 3 inclusion and 8 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 4 Nov 2019. 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?
Cmax (time frame: From Period1/ Day1 to Period2/Day9). The study lists 2 primary outcomes in all. 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 4 Nov 2019.