HealthyPhase 1NCT03826641
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
A Phase 1 study testing HCP1805 and HCP1801 in people with Healthy, 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, safety and tolerability of HCP1801 in healthy subjects. 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?
- HCP1805 and HCP1801
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 16 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19~45 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 29.9 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: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.
- Conditions
- Healthy
- Being tested
- HCP1805, HCP1801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1805Drug
Dapagliflozin/Metformin (Xigduo XR) 10/1000mg
HCP1801Drug
Dapagliflozin/Metformin 10/1000mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801 Receives: Drug: HCP1805; Drug: HCP1801 |
| Sequence 2 | Experimental | Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805 Receives: Drug: HCP1805; Drug: HCP1801 |
| Sequence 3 | Experimental | Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 Receives: Drug: HCP1805; Drug: HCP1801 |
| Sequence 4 | Experimental | Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 Receives: Drug: HCP1805; Drug: HCP1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
AUClast of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Cmax of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
AUClast of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Secondary outcomes (10)
AUCinf of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Tmax of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
t1/2 of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
CL/F of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Vd/F of Dapagliflozin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
AUCinf of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Tmax of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
t1/2 of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
CL/F of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Vd/F of Metformin
pharmacokinetic evaluation
Measured: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Feb 2019
- Primary completion25 Mar 2019
- Study completion16 Apr 2019
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 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
- 85 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
- NCT03826641
- Sponsor's protocol ID
- HM-DAME-101
- Status last verified
- Jul 2022
- First submitted
- 28 Jan 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03826641
- Acronym / sponsor ID
- HM-DAME-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 1 Feb 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, safety and tolerability of HCP1801 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HCP1805, Drug: HCP1801Period 1 : Fasted state + HCP1805, Period 2 : Fasted state + HCP1801 |
| Sequence 2 | Experimental | Drug: HCP1805, Drug: HCP1801Period 1 : Fasted state + HCP1801, Period 2 : Fasted state + HCP1805 |
| Sequence 3 | Experimental | Drug: HCP1805, Drug: HCP1801Period 1 : High fat diet + HCP1805, Period 2 : High fat diet + HCP1801 |
| Sequence 4 | Experimental | Drug: HCP1805, Drug: HCP1801Period 1 : High fat diet + HCP1801, Period 2 : High fat diet + HCP1805 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 19~45 years in healthy volunteers
- BMI is more than 18.5 kg/m^2 , no more than 29.9 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 |
|---|---|---|
| HCP1805Dapagliflozin/Metformin (Xigduo XR) 10/1000mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| HCP1801Dapagliflozin/Metformin 10/1000mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Cmax of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
AUClast of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
Cmax of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
AUClast of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
pharmacokinetic evaluation
10 secondary outcomes
AUCinf of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Tmax of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
t1/2 of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
CL/F of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Vd/F of Dapagliflozin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
AUCinf of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Tmax of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
t1/2 of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
CL/F of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour
Vd/F of Metformin
Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 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 14 Jul 2022.
- 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 HCP1805 and HCP1801 in people with Healthy, 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 14 Jul 2022. 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 Dapagliflozin (time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 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 14 Jul 2022.