HealthyPhase 4NCT02344563
Bioequivalence of Two Formulations of Meropenem Intravenous Injection
A Phase 4 study testing Meropem and Mepem in people with Healthy, run by Yung Shin Pharm. Ind. Co., Ltd..
Trial summary
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meropem and Mepem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female subjects between 20-45 years of age.
- Body weight within 80-120% of ideal body weight and higher than or equal to 50 kg for male subjects and 45 kg for female subjects.
- Ideal body weight (kg) = [height (cm) - 80] × 0.7 for male subjects
- Ideal body weight (kg) = [height (cm) - 70] × 0.6 for female subjects
- Acceptable medical history and physical examination including:
- no particular clinically significant abnormality in X-ray and ECG results within six months prior to study. no particular clinical significance in general disease history within two months prior to study.
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- Acceptable vital signs (within normal limits or considered by the investigator or physician to be of no clinical significance) at screening, which includes pulse rate, blood pressure and body temperature.
- Acceptable clinical chemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study, which includes AST (SGOT), ALT (SGPT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride (TG).
- Acceptable hematology (within normal range or considered by the investigator or physician to be of no clinical significance) within two months prior to study, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
- Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study, which includes pH, blood, glucose, ketones, bilirubin and protein.
- Female subjects of childbearing potential practicing an acceptable method of birth control from at least seven days prior to study until the end of study as judged by the investigator(s) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on the subject).
- Have signed the written informed consent to participate in the study.
Who cannot join
- A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- A clinically significant illness or surgery within four weeks prior to study (as determined by the investigator).
- History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- Known or suspected history of drug abuse within lifetime as judged by the investigator.
- History of alcohol addiction or abuse within last five years as judged by the investigator.
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- Have a personal history or family history of drug allergy.
- Subjects demonstrating a positive meropenem skin test screen prior to the study.
- Evidence of chronic or acute infectious diseases.
- Female subjects demonstrating a positive urine pregnancy screen prior to study.
- Female subjects who are currently breastfeeding.
- Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to study. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
- Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to study.
- Use of any investigational drug within four weeks prior to study.
- Donating more than 250 mL of blood within two months prior to study or donating plasma (e.g. plasmapheresis) within two weeks prior to study.
- Any other medical reason as determined by the clinical investigator.
About this study
Official title: A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Meropenem In Healthy Volunteers(Meropenem Intravenous Injection) After Intravenous Infusion
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Meropem, Mepem
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropemDrug
MepemDrug
| Study group | Role | What they receive |
|---|---|---|
| Meropem | Experimental | 0.5g/vial,one vial Receives: Drug: Meropem; Drug: Mepem |
| Mepem | Active comparator | 0.25g/vial ,two vials Receives: Drug: Meropem; Drug: Mepem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and incidences
Measured: predose to 6 hours post dose
Secondary outcomes (1)
Pharmacokinetic parameters
Measured: pre dose to 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionDec 2014
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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhi-Yuan Shi, M.D., Principal investigator, zyshi@vghtc.gov.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344563
- Sponsor's protocol ID
- YSP-RBH3012-03
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Meropenem In Healthy Volunteers(Meropenem Intravenous Injection) After Intravenous Infusion
- ClinicalTrials.gov ID
- NCT02344563
- Acronym / sponsor ID
- YSP-RBH3012-03
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jan 2015 (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.
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropem | Experimental | Drug: Meropem, Drug: Mepem0.5g/vial,one vial |
| Mepem | Active comparator | Drug: Meropem, Drug: Mepem0.25g/vial ,two vials |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult male or female subjects between 20-45 years of age.
- Body weight within 80-120% of ideal body weight and higher than or equal to 50 kg for male subjects and 45 kg for female subjects.
- Acceptable medical history and physical examination including:
- no particular clinically significant abnormality in X-ray and ECG results within six months prior to study. no particular clinical significance in general disease history within two months prior to study.
- Acceptable vital signs (within normal limits or considered by the investigator or physician to be of no clinical significance) at screening, which includes pulse rate, blood pressure and body temperature.
Key exclusion criteria (16 listed)
- A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- A clinically significant illness or surgery within four weeks prior to study (as determined by the investigator).
- History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- Known or suspected history of drug abuse within lifetime as judged by the investigator.
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 |
|---|---|---|
| Meropem | Drug | Mepem, Meropem |
| Mepem | Drug | Mepem, Meropem |
Primary outcome
Adverse events and incidences
Time frame: predose to 6 hours post dose
1 secondary outcome
Pharmacokinetic parameters
Time frame: pre dose to 6 hours post dose
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 26 Jan 2015.
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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.
Zhi-Yuan Shi, M.D. principal investigator
zyshi@vghtc.gov.tw
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropem and Mepem in people with Healthy, run by Yung Shin Pharm. Ind. 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 12 inclusion and 16 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 26 Jan 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Adverse events and incidences (time frame: predose to 6 hours post dose). 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 26 Jan 2015.