Atrial FibrillationPhase 1NCT04764201
The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
A Phase 1 study testing HIP2001 and HGP2001 in people with Atrial Fibrillation, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- HIP2001 and HGP2001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2021to 8 Mar 2021
- 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
- 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
- agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
Who cannot join
- A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
- A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
- A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
- Positive results of serological tests
- Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
- Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
Show all 10Show fewer
- Have drank more than 210 g/week of alcohol within 30 days before the screening date
- Have smoked more than 10 bills/day within 30 days before the screening date
- AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR < 50 mL/min/1.73m2, Prothrombin (INR) > 1.31 INR or aPTT > 39.7 sec
- 12-ECG QTc >450 ms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.
- Conditions
- Atrial Fibrillation
- Being tested
- HIP2001, HGP2001
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP2001Drug
Test drug
HGP2001Drug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Period 1: HGP2001, Period 2: HIP2001 Receives: Drug: HIP2001; Drug: HGP2001 |
| Sequence 2 | Other | Period 1: HIP2001, Period 2: HGP2001 Receives: Drug: HIP2001; Drug: HGP2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Pharmacokinetic evaluation
Measured: 0~48 hours
Cmax
Pharmacokinetic evaluation
Measured: 0~48 hours
Secondary outcomes (5)
AUCinf
Pharmacokinetic evaluation
Measured: 0~48 hours
Tmax
Pharmacokinetic evaluation
Measured: 0~48 hours
t1/2
Pharmacokinetic evaluation
Measured: 0~48 hours
CL/F
Pharmacokinetic evaluation
Measured: 0~48 hours
Vd/F
Pharmacokinetic evaluation
Measured: 0~48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start16 Jan 2021
- Primary completion26 Feb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingeul Kim, Principal investigator, Jeonbuk University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764201
- Sponsor's protocol ID
- HM-EDOX-101
- Status last verified
- Mar 2021
- First submitted
- 15 Feb 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04764201
- Acronym / sponsor ID
- HM-EDOX-101
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 21 Feb 2021 (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.
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Drug: HIP2001, Drug: HGP2001Period 1: HGP2001, Period 2: HIP2001 |
| Sequence 2 | Other | Drug: HIP2001, Drug: HGP2001Period 1: HIP2001, Period 2: HGP2001 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight >60kg
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <900 mmHg
- agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
Key exclusion criteria (10 listed)
- A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
- A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
- A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
- Positive results of serological tests
- Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
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 |
|---|---|---|
| HIP2001Test drug | Drug | Sequence 1, Sequence 2 |
| HGP2001Reference drug | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCt
Time frame: 0~48 hours
Pharmacokinetic evaluation
Cmax
Time frame: 0~48 hours
Pharmacokinetic evaluation
5 secondary outcomes
AUCinf
Time frame: 0~48 hours
Tmax
Time frame: 0~48 hours
t1/2
Time frame: 0~48 hours
CL/F
Time frame: 0~48 hours
Vd/F
Time frame: 0~48 hours
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 1 Apr 2021.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Mingeul Kim principal investigator
Jeonbuk 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 HIP2001 and HGP2001 in people with Atrial Fibrillation, 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 10 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 1 Apr 2021. 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?
AUCt (time frame: 0~48 hours). 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 1 Apr 2021.