Health, SubjectivePhase 1NCT04081857
A Study to Evaluate the Pharmacokinetics and Safety of HCP1704 in Healthy Subjects
A Phase 1 study testing HGP1810 and HCP1704 in people with Health, Subjective, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- HGP1810 and HCP1704
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2019to 5 Aug 2019
- 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
- Age 19~55 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.
- Conditions
- Health, Subjective
- Being tested
- HGP1810, HCP1704
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGP1810Drug
HGP1810: Vildagliptin/Metformin
HCP1704Drug
HCP1704: Vildagliptin/Metformin
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704 Receives: Drug: HGP1810; Drug: HCP1704 |
| Sequence 2 | Experimental | Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810 Receives: Drug: HGP1810; Drug: HCP1704 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
AUClast of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Cmax of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
AUClast of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Secondary outcomes (10)
AUCinf of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Tmax of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
t1/2 of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
CL/F of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Vd/F of Vildagliptin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
AUCinf of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Tmax of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
t1/2 of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
CL/F of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Vd/F of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start3 Jun 2019
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081857
- Sponsor's protocol ID
- HM-VIME-102
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04081857
- Acronym / sponsor ID
- HM-VIME-102
- Conditions
- Health, Subjective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- 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.
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HGP1810, Drug: HCP1704Period 1 : Fasted state + HGP1810 Period 2 : Fasted state + HCP1704 |
| Sequence 2 | Experimental | Drug: HGP1810, Drug: HCP1704Period 1 : Fasted state + HCP1704 Period 2 : Fasted state + HGP1810 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 19~55 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible 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 |
|---|---|---|
| HGP1810HGP1810: Vildagliptin/Metformin | Drug | Sequence 1, Sequence 2 |
| HCP1704HCP1704: Vildagliptin/Metformin | Drug | Sequence 1, Sequence 2 |
Primary outcome
Cmax of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
AUClast of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
Cmax of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
AUClast of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
pharmacokinetic evaluation
10 secondary outcomes
AUCinf of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Tmax of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
t1/2 of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
CL/F of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Vd/F of Vildagliptin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
AUCinf of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Tmax of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
t1/2 of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
CL/F of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
Vd/F of Metformin
Time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour
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 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HGP1810 and HCP1704 in people with Health, Subjective, run by Hanmi Pharmaceutical Company Limited 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 2 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 Sep 2019. 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?
Cmax of Vildagliptin (time frame: pre-dose(0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hour). 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 9 Sep 2019.