HealthyPhase 4NCT02255734
Bioequivalence of Two Formulations of Acyclovir
A Phase 4 study testing Acyclovir in people with Healthy, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial summary
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg) 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?
- Acyclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Apr 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 to 45 years of age
- Body weight within 80 to 120 percentages 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 period I dosing.no particular clinical significance in general disease history within two months prior to period I dosing
- 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 Period I dosing, which includes AST , ALT ,GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride
- Acceptable hematology within normal range or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets
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- Acceptable urinalysis within normal limits or considered by the investigator or physician to be of no clinical significance within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein
- Female subjects of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators 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 systems or psychiatric disease as determined by the clinical investigator
- A clinically significant illness or surgery within four weeks prior to Period I dosing 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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- History of allergic responses to acyclovir, valacyclovir or any other related drugs
- Evidence of chronic or acute infectious diseases
- Female subjects demonstrating a positive urine pregnancy screen prior to the study
- Female subjects who are currently breastfeeding
- Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. 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 Period I dosing
Trial locations and contacts
1 site in 1 country.
About this study
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg) after Intravenous Infusion in Healthy Volunteers.
- Conditions
- Healthy
- Being tested
- Acyclovir
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| Zovirax | Active comparator | Not described Receives: Drug: Acyclovir |
| Virless | Experimental | Not described Receives: Drug: Acyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration
Measured: Day 1, Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionApr 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
- Primary purpose
- Treatment
- 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
- Po-Yen Chen, M.D., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255734
- Sponsor's protocol ID
- YSP-REH3002-01
- Status last verified
- Sep 2014
- First submitted
- 14 May 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Formulations of Acyclovir
- ClinicalTrials.gov ID
- NCT02255734
- Acronym / sponsor ID
- YSP-REH3002-01
- 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
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- First posted
- 3 Oct 2014 (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.
Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg) after Intravenous Infusion in Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zovirax | Active comparator | Drug: Acyclovir |
| Virless | Experimental | Drug: Acyclovir |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult male or female subjects between 20 to 45 years of age
- Body weight within 80 to 120 percentages 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 period I dosing.no particular clinical significance in general disease history within two months prior to period I dosing
- 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 Period I dosing, which includes AST , ALT ,GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride
Key exclusion criteria (12 listed)
- A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic systems or psychiatric disease as determined by the clinical investigator
- A clinically significant illness or surgery within four weeks prior to Period I dosing 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 |
|---|---|---|
| Acyclovir | Drug | Virless, Zovirax |
Primary outcome
Plasma drug concentration
Time frame: Day 1, Day 2
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 3 Oct 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.
Po-Yen Chen, M.D. principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acyclovir in people with Healthy, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
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 9 inclusion and 12 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 3 Oct 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 Taiwan. 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 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?
Plasma drug concentration (time frame: Day 1, Day 2). 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 3 Oct 2014.