HealthyPhase 1NCT01073059
Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects
A Phase 1 study testing Valproic acid and Ertapenem in people with Healthy, run by Chonbuk National University at 1 site in South Korea.
Trial summary
This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid \& ertapenem combination treatment This trial is performed to evaluate safety of the combination treatment compare with single treatment The investigators carry this trial out to… 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
- Healthy
- What is being tested?
- Valproic acid and Ertapenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to not given
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are healthy volunteers, men 19~50 years
- Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight
Who cannot join
- Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease
- Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
- Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
- Subjects with a history of drug abuse
- Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week
- Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration
- Subjects who are chronic drinkers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
About this study
Official title: Open-label, Two-period, One Sequence, Multiple Dose, Crossover Study, A Study to Investigate Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Healthy Male Subjects
- This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid \& ertapenem combination treatment
- This trial is performed to evaluate safety of the combination treatment compare with single treatment
- The investigators carry this trial out to study mechanism of combination treatment
- Conditions
- Healthy
- Being tested
- Valproic acid and Ertapenem
- Keywords
- valproic acid, ertapenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic acid and ErtapenemDrug
| Study group | Role | What they receive |
|---|---|---|
| Valproic acid | Experimental | Not described Receives: Drug: Valproic acid and Ertapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment
Measured: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment
Measured: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid single treatment
Measured: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment
Measured: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startAug 2009
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University
- Sponsor type
- University, hospital or other
- Investigators
- Chang-Seop Lee, MD/Prof., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073059
- Sponsor's protocol ID
- CUH_2009_VPA
- Status last verified
- Feb 2010
- First submitted
- 19 Feb 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Two-period, One Sequence, Multiple Dose, Crossover Study, A Study to Investigate Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01073059
- Acronym / sponsor ID
- CUH_2009_VPA
- Conditions
- Healthy
- Keywords
- valproic acid, ertapenem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chonbuk National UniversityUniversity, hospital or other
- Study start
- Aug 2009
- First posted
- 23 Feb 2010 (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.
- This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid \& ertapenem combination treatment
- This trial is performed to evaluate safety of the combination treatment compare with single treatment
- The investigators carry this trial out to study mechanism of combination treatment
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valproic acid | Experimental | Drug: Valproic acid and Ertapenem |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects who are healthy volunteers, men 19~50 years
- Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight
Key exclusion criteria (8 listed)
- Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease
- Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
- Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
- Subjects with 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 |
|---|---|---|
| Valproic acid and Ertapenem | Drug | Valproic acid |
Primary outcome
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment
Time frame: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid and Ertapenem combination treatment
Time frame: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid single treatment
Time frame: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol
Area Under the Concentration Versus Time Curve in Valproic acid and Ertapenem combination treatment
Time frame: serial pharmacokinetic plasma concentrations were drawn at 144, 145, 146, 147, 148, 149, 150, 152, and 156 hours according to protocol
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 8 Dec 2010.
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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.
Chang-Seop Lee, MD/Prof. principal investigator
Chonbuk National University Hospital
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 Valproic acid and Ertapenem in people with Healthy, run by Chonbuk National University 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 2 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 8 Dec 2010. 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?
Maximum Plasma Concentration at Steady State (Cmax ss) in Valproic acid single treatment (time frame: serial pharmacokinetic plasma concentrations were drawn at 72, 73, 74, 75, 76, 77, 78, 80, and 84 hours according to protocol). The study lists 4 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 8 Dec 2010.