HealthyPhase 1NCT02125227
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
A Phase 1 study testing Rosuvastatin, Metformin, YH14755 and YH14755 in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin, Metformin, YH14755 and YH14755
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Sep 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- Administration of other investigational products within 3 months prior to the first dosing.
- Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561712
About this study
Official title: A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755
The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Metformin, YH14755, YH14755
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin, Metformin, YH14755Drug
Also called Crestor, GlucodaunOR, YH14755
single dose
YH14755Drug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 of Study A | Experimental | single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755 Receives: Drug: Rosuvastatin, Metformin, YH14755 |
| Group 2 of Study A | Experimental | single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin Receives: Drug: Rosuvastatin, Metformin, YH14755 |
| Group 1 of Study B | Experimental | single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast Receives: Drug: YH14755 |
| Group 2 of Study B | Experimental | single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state Receives: Drug: YH14755 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
Cmax of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
Secondary outcomes (4)
Tmax of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
t1/2 of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
%AUC of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
AUCinf of rosuvastatin and metformin
Measured: 0~48hr, totally 17 points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 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.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, MD, Ph.D, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125227
- Sponsor's protocol ID
- YH14755-102
- Status last verified
- Oct 2014
- First submitted
- 24 Apr 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755
- ClinicalTrials.gov ID
- NCT02125227
- Acronym / sponsor ID
- YH14755-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Apr 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.
The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 of Study A | Experimental | Drug: Rosuvastatin, Metformin, YH14755single dosing of Rosuvastatin and Metformin 14 days later, single dosing of YH14755 |
| Group 2 of Study A | Experimental | Drug: Rosuvastatin, Metformin, YH14755single dosing of YH14755 14 days later, single dosing of Rosuvastatin and Metformin |
| Group 1 of Study B | Experimental | Drug: YH14755single dosing of YH14755 with fasting state 14 days later, single dosing of YH14755 after having breakfast |
| Group 2 of Study B | Experimental | Drug: YH14755single dosing of YH14755 after having breakfast 14 days later, single dosing of YH14755 with fasting state |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Key exclusion criteria (5 listed)
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- Administration of other investigational products within 3 months prior to the first dosing.
- Administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
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 |
|---|---|---|
| Rosuvastatin, Metformin, YH14755Also: Crestor, GlucodaunOR, YH14755single dose | Drug | Group 1 of Study A, Group 2 of Study A |
| YH14755single dose | Drug | Group 1 of Study B, Group 2 of Study B |
Primary outcome
AUClast of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
Cmax of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
4 secondary outcomes
Tmax of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
t1/2 of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
%AUC of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
AUCinf of rosuvastatin and metformin
Time frame: 0~48hr, totally 17 points
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 9 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.
Mingul Kim, MD, Ph.D 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 Rosuvastatin, Metformin, YH14755 and YH14755 in people with Healthy, run by Yuhan Corporation 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 3 inclusion and 5 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 9 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 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?
AUClast of rosuvastatin and metformin (time frame: 0~48hr, totally 17 points). The study lists 2 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 9 Oct 2014.