HealthyPhase 1NCT02586363
Study of Evaluation of Cavir Tab. 0.5mg With Food Effect on Pharmacokinetics and Safety
A Phase 1 study testing Baraclude Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, fasting and Cavir Tab. 0.5mg, high fatty meal in people with Healthy, run by Seoul St. Mary's Hospital.
Trial summary
In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer. The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Baraclude Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, fasting and Cavir Tab. 0.5mg, high fatty meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, aged 19 ~ 45 at screening date
- Subject's weight is in range from -120 percentage to +120 percentage of ideal body weight which is calculated by { height (cm) - 100} * 0.9.
- The Subject is willing and able to provide written informed consent to participate in the study
Who cannot join
- Subject has a history of clinically significant disease.
- Subject has a digestive disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc) or abdomen surgery (exclude, simple appendectomy or hernia operation).
- Subject has a hypersensitivity history which is clinically significance or additives.
- Subject is inappropriate to screening (disease history, physical examination, vital sings, electrocardiogram, laboratory test etc.)
- Subject has a laboratory test result as indicated by and one of the following.
- serum aspartate aminotransferase> 1.25 * normal limit
Show all 12Show fewer
- serum Total bilirubin > 1.5 * normal upper limit
- serum CPK > 1.5 * normal upper limit
- eGFR(estimated Glomerular Filtration Rate) calaulated by MDRD (Modification of Diet in Renal Disease) formula < 60 mL/min/1.73m2
- Subject is hypertension(SBP>140mmHg or DBP>90mmHg) or hypotension(SBP<90mmHg, DBP<60mmHg)
- Subject has a drug abusing history.
- Subject is currently abusing alcohol (more than 210 g/week), caffeine(more than 5cups/day) or smoking(more than half pack).
About this study
Official title: A Randomized, Open-label, 3-way Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics and Safety of Single-dose Cavir Tab. 0.5mg With Baraclude Tab. 0.5mg in Healthy Male Volunteers
In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer.
The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.
- Conditions
- Healthy
- Being tested
- Baraclude Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, high fatty meal
- Keywords
- Entecavir, Food effect, Cavir Tab 0.5mg, Baraclude Tab. 0.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baraclude Tab. 0.5mg, fastingDrug
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
Cavir Tab. 0.5mg, fastingDrug
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
Cavir Tab. 0.5mg, high fatty mealDrug
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
| Study group | Role | What they receive |
|---|---|---|
| Baraclude Tab. 0.5mg, fasting | Active comparator | Single dose Baraclude Tab. 0.5mg, fasting state Receives: Drug: Baraclude Tab. 0.5mg, fasting |
| Cavir Tab. 0.5mg, fasting | Experimental | Single dose Cavir Tab. 0.5mg, fasting state Receives: Drug: Cavir Tab. 0.5mg, fasting |
| Cavir Tab. 0.5mg, high fatty meal | Experimental | Single dose Cavir Tab. 0.5mg, high fatty meal Receives: Drug: Cavir Tab. 0.5mg, high fatty meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of Entecavir.
phamacokinetic parameter
Measured: Within 6 Months After Final Visit of Subject
Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
phamacokinetic parameter
Measured: Within 6 Months After Final Visit of Subject.
Number of participants with adverse events.
Measured: Within 6 Months After Final Visit of Subject
Secondary outcomes (3)
Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.
Pharmacokinetic parameter
Measured: Within 6 Months After Final Visit of Subject.
The time at which the Cmax is observed (Tmax) of entecavir.
Pharmacokinetic parameter, Cmax is the peak plasma concentration.
Measured: Within 6 Months After Final Visit of Subject.
Terminal half-life (T1/2) of entecavir.
Pharmacokinetic parameter
Measured: Within 6 Months After Final Visit of Subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-seok Yim, Seoul St. Mary's Hospital
- Investigators
- Dong-Seok Yim, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586363
- Sponsor's protocol ID
- Cavir food effect study
- Status last verified
- Dec 2015
- First submitted
- 15 Oct 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 3-way Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics and Safety of Single-dose Cavir Tab. 0.5mg With Baraclude Tab. 0.5mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02586363
- Acronym / sponsor ID
- Cavir food effect study
- Conditions
- Healthy
- Keywords
- Entecavir, Food effect, Cavir Tab 0.5mg, Baraclude Tab. 0.5mg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 26 Oct 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.
In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer.
The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baraclude Tab. 0.5mg, fasting | Active comparator | Drug: Baraclude Tab. 0.5mg, fastingSingle dose Baraclude Tab. 0.5mg, fasting state |
| Cavir Tab. 0.5mg, fasting | Experimental | Drug: Cavir Tab. 0.5mg, fastingSingle dose Cavir Tab. 0.5mg, fasting state |
| Cavir Tab. 0.5mg, high fatty meal | Experimental | Drug: Cavir Tab. 0.5mg, high fatty mealSingle dose Cavir Tab. 0.5mg, high fatty meal |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male, aged 19 ~ 45 at screening date
- Subject's weight is in range from -120 percentage to +120 percentage of ideal body weight which is calculated by { height (cm) - 100} * 0.9.
- The Subject is willing and able to provide written informed consent to participate in the study
Key exclusion criteria (12 listed)
- Subject has a history of clinically significant disease.
- Subject has a digestive disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc) or abdomen surgery (exclude, simple appendectomy or hernia operation).
- Subject has a hypersensitivity history which is clinically significance or additives.
- Subject is inappropriate to screening (disease history, physical examination, vital sings, electrocardiogram, laboratory test etc.)
- Subject has a laboratory test result as indicated by and one of the following.
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 |
|---|---|---|
| Baraclude Tab. 0.5mg, fastingAfter drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) | Drug | Baraclude Tab. 0.5mg, fasting |
| Cavir Tab. 0.5mg, fastingAfter drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) | Drug | Cavir Tab. 0.5mg, fasting |
| Cavir Tab. 0.5mg, high fatty mealAfter drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) | Drug | Cavir Tab. 0.5mg, high fatty meal |
Primary outcome
Peak plasma concentration (Cmax) of Entecavir.
Time frame: Within 6 Months After Final Visit of Subject
phamacokinetic parameter
Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
Time frame: Within 6 Months After Final Visit of Subject.
phamacokinetic parameter
Number of participants with adverse events.
Time frame: Within 6 Months After Final Visit of Subject
3 secondary outcomes
Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.
Time frame: Within 6 Months After Final Visit of Subject.
The time at which the Cmax is observed (Tmax) of entecavir.
Time frame: Within 6 Months After Final Visit of Subject.
Terminal half-life (T1/2) of entecavir.
Time frame: Within 6 Months After Final Visit of Subject.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Dong-Seok Yim, MD, PhD principal investigator
Seoul St. Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baraclude Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, fasting and Cavir Tab. 0.5mg, high fatty meal in people with Healthy, run by Seoul St. Mary's Hospital.
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 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: status not confirmed, as of the sponsor's last update on 3 Dec 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 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?
Results are not available in the source record.
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?
Peak plasma concentration (Cmax) of Entecavir. (time frame: Within 6 Months After Final Visit of Subject). The study lists 3 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 3 Dec 2015.