Therapeutic EquivalencyNCT00997789
Bioequivalence of Rebamipide in Korean
A study testing Rebamide in people with Therapeutic Equivalency and Pharmacogenetics, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of two rebamipide preparations in healthy Korean male volunteers for generic substitution and to evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and rebamipide disposition. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency, Pharmacogenetics
- What is being tested?
- Rebamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Dec 2008
- Phase
- Interventional
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, differential counting of WBC, total proteins, albumin, ALT, AST, alkaline phosphatase, total bilirubin, cholesterol, creatinine, blood urea nitrogen, and fasting glucose and urine analysis; specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and cast).
Who cannot join
- Subjects possibly sensitive to this type of preparation,
- Subjects who had a history of any hepatic illness,
- Subjects who had a history of any renal illness,
- Subjects who had a history of any respiratory illness,
- Subjects who had a history of any endocrine illness,
- Subjects who had a history of any cardiovascular system illness,
- Subjects who had taken alcohol within 4 weeks prior to the study,
- Subjects who had taken other preparations within 4 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Bioeqivalence and Bridging Study, College of Pharmacy, CNU
Gwangju, 500-757
About this study
Official title: Bioequivalence Evaluation of Two Rebamipide Preparations After a Single Oral Dose to Healthy Korean Volunteers
The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of two rebamipide preparations in healthy Korean male volunteers for generic substitution and to evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and rebamipide disposition.
Read the detailed description
A randomized, single-dose, 2-period crossover design with a 7-day washout period was conducted in 30 healthy Korean male volunteers. Subjects were randomly assigned to receive a single 100-mg dose of the test or reference preparation of rebamipide, administered with 240 mL of water after a 12-hour overnight fast. All subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Serum concentrations of rebamipide up to 12 hours after administration were determined using a validated HPLC method with fluorescence detection. Adverse events (AEs) were continuously monitored by clinical staff via observation, personal interview, and vital signs (temperature, blood pressure, heart rate) during the study period. All adverse events were recorded on the clinical record form per subject up to 1 week after the study. Pharmacokinetic parameters were determined using a noncompartmental method. The preparations were considered bioequivalent if the log-transformed ratios of AUC0-t, AUC0-∞, and Cmax were within the predetermined bioequivalence range (ie, 80-125%), as set by the US Food and Drug Administration (FDA) and Korean legislation. In vitro dissolution profiles of both preparations were examined and the influence of genetic polymorphisms in ABCB1 gene (P-glycoprotein) on the pharmacokinetics of rebamipide was also investigated.
- Conditions
- Therapeutic Equivalency, Pharmacogenetics
- Being tested
- Rebamide
- Keywords
- Rebamipide, Bioequivalence, ABCB1 genetic polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamideDrug
Also called Mucosta® (Korea Otsuka Pharmaceuticals Co.)
Rebamipide 100 mg Tablet, three times a day
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide, Serum concentration, Tablet | Experimental | The test preparation, Rebamide® (containing 100 mg of rebamipide; lot No. KP005; expiration date, April 2010; Kyungdong Pharmaceutical Company, Seoul, Korea) and the reference preparation, Mucosta® (containing 100 mg of rebamipide; lot No. MC704067; expiration date, May 2010; Korea Otsuka Pharmaceuticals Co., Ltd., Seoul, Korea) Receives: Drug: Rebamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of rebamipide
Measured: Pre-dose (to serve as a control) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 12 hours after oral administration of rebamipide tablet (100 mg)
Secondary outcomes (1)
Genetic polymorphisms in ABCB1 gene (exon 21 and 26)
Measured: A 3-mL blood sample was taken from each subject who participated in our bioequivalence studies before administration of rebamipide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic EquivalencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
- Investigators
- Yong-Bok Lee, Ph.D., Principal investigator, Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997789
- Sponsor's protocol ID
- IBBS-BE-REBAMIPIDE-KYUNGDONG
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho HY, Yoon H, Park GK, Lee YB. Pharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers. Clin Ther. 2009 Nov;31(11):2712-21. doi: 10.1016/j.clinthera.2009.11.010.
PubMed 20110013
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Evaluation of Two Rebamipide Preparations After a Single Oral Dose to Healthy Korean Volunteers
- ClinicalTrials.gov ID
- NCT00997789
- Acronym / sponsor ID
- IBBS-BE-REBAMIPIDE-KYUNGDONG
- Conditions
- Therapeutic Equivalency, Pharmacogenetics
- Keywords
- Rebamipide, Bioequivalence, ABCB1 genetic polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Oct 2009 (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.
The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of two rebamipide preparations in healthy Korean male volunteers for generic substitution and to evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and rebamipide disposition.
Detailed description
A randomized, single-dose, 2-period crossover design with a 7-day washout period was conducted in 30 healthy Korean male volunteers. Subjects were randomly assigned to receive a single 100-mg dose of the test or reference preparation of rebamipide, administered with 240 mL of water after a 12-hour overnight fast. All subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Serum concentrations of rebamipide up to 12 hours after administration were determined using a validated HPLC method with fluorescence detection. Adverse events (AEs) were continuously monitored by clinical staff via observation, personal interview, and vital signs (temperature, blood pressure, heart rate) during the study period. All adverse events were recorded on the clinical record form per subject up to 1 week after the study. Pharmacokinetic parameters were determined using a noncompartmental method. The preparations were considered bioequivalent if the log-transformed ratios of AUC0-t, AUC0-∞, and Cmax were within the predetermined bioequivalence range (ie, 80-125%), as set by the US Food and Drug Administration (FDA) and Korean legislation. In vitro dissolution profiles of both preparations were examined and the influence of genetic polymorphisms in ABCB1 gene (P-glycoprotein) on the pharmacokinetics of rebamipide was also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebamipide, Serum concentration, Tablet | Experimental | Drug: RebamideThe test preparation, Rebamide® (containing 100 mg of rebamipide; lot No. KP005; expiration date, April 2010; Kyungdong Pharmaceutical Company, Seoul, Korea) and the reference preparation, Mucosta® (containing 100 mg of rebamipide; lot No. MC704067; expiration date, May 2010; Korea Otsuka Pharmaceuticals Co., Ltd., Seoul, Korea) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, differential counting of WBC, total proteins, albumin, ALT, AST, alkaline phosphatase, total bilirubin, cholesterol, creatinine, blood urea nitrogen, and fasting glucose and urine analysis; specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and cast).
Key exclusion criteria (8 listed)
- Subjects possibly sensitive to this type of preparation,
- Subjects who had a history of any hepatic illness,
- Subjects who had a history of any renal illness,
- Subjects who had a history of any respiratory illness,
- Subjects who had a history of any endocrine illness,
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 |
|---|---|---|
| RebamideAlso: Mucosta® (Korea Otsuka Pharmaceuticals Co.)Rebamipide 100 mg Tablet, three times a day | Drug | Rebamipide, Serum concentration, Tablet |
Primary outcome
Serum concentration of rebamipide
Time frame: Pre-dose (to serve as a control) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 12 hours after oral administration of rebamipide tablet (100 mg)
1 secondary outcome
Genetic polymorphisms in ABCB1 gene (exon 21 and 26)
Time frame: A 3-mL blood sample was taken from each subject who participated in our bioequivalence studies before administration of rebamipide.
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 19 Oct 2009.
- Derived from this study: PubMed 20110013Cho HY, Yoon H, Park GK, Lee YB. Pharmacokinetics and bioequivalence of two formulations of rebamipide 100-mg tablets: a randomized, single-dose, two-period, two-sequence crossover study in healthy Korean male volunteers. Clin Ther. 2009 Nov;31(11):2712-21. doi: 10.1016/j.clinthera.2009.11.010.
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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.
Yong-Bok Lee, Ph.D. principal investigator
Institute of Bioequivalence and Bridging Study, College of Pharmacy, CNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebamide in people with Therapeutic Equivalency and Pharmacogenetics, run by Chonnam National University Hospital 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 1 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 19 Oct 2009. 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.
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?
Serum concentration of rebamipide (time frame: Pre-dose (to serve as a control) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 12 hours after oral administration of rebamipide tablet (100 mg)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997789, which also lists 1 linked publication.
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 19 Oct 2009.