HealthyPhase 1NCT04018378
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
A Phase 1 study testing varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT and varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR in people with Healthy, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT and varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2017to 17 Sep 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
- Subject who voluntarily agrees to participate in this study and signs the informed consent form.
Who cannot join
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
- With symptoms indicating acute illness within 28 days prior to the first IP administration.
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
- Any clinically significant activity of chronic medical illness.
- History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
- Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
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- Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration.
- Inability to take standard hospital diet.
- Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration.
- Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
- Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
- Any use of tobacco or nicotine within three months.
- Subjects rejected to use clinically effective contraceptive methods during the study period.
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, 136-705
About this study
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT, varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RTDrug
varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TRDrug
varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
| Study group | Role | What they receive |
|---|---|---|
| RT | Experimental | period 1: HGP1604 1mg (reference drug, R) will be administered once orally.
period 2: HIP1502 1mg (test drug, T) will be administered once orally after 14 days of the washout period. Receives: Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT |
| TR | Experimental | period 1: HIP1502 1mg (test drug, T) will be administered once orally.
period 2: HGP1604 1mg (reference drug, R) will be administered once orally after 14 days of the washout period. Receives: Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
area under the plasma concentration-time curve
Measured: 0 (predose) ~ 96 hours
Cmax
maximum plasma concentration of the drug
Measured: 0 (predose) ~ 96 hours
Secondary outcomes (4)
Tmax
time to maximum plasma concentration
Measured: 0 (predose) ~ 96 hours
T1/2
terminal elimination half-life
Measured: 0 (predose) ~ 96 hours
CL/F
apparent total body clearance of the drug from plasma
Measured: 0 (predose) ~ 96 hours
Vd/F
apparent volume of distribution
Measured: 0 (predose) ~ 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start6 Jan 2017
- Primary completion15 May 2017
- Study completion17 Sep 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- an open-label, randomized, single-dose crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Young Park, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018378
- Sponsor's protocol ID
- HM-VANC-101
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jul 2019. 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 HIP1502 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04018378
- Acronym / sponsor ID
- HM-VANC-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 12 Jul 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.
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open-label, randomized, single-dose crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| RT | Experimental | Drug: varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RTperiod 1: HGP1604 1mg (reference drug, R) will be administered once orally. period 2: HIP1502 1mg (test drug, T) will be administered once orally after 14 days of the washout period. |
| TR | Experimental | Drug: varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TRperiod 1: HIP1502 1mg (test drug, T) will be administered once orally. period 2: HGP1604 1mg (reference drug, R) will be administered once orally after 14 days of the washout period. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged between ≥20 and ≤45 years old
- Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
- Subject who voluntarily agrees to participate in this study and signs the informed consent form.
Key exclusion criteria (14 listed)
- History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
- With symptoms indicating acute illness within 28 days prior to the first IP administration.
- Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
- Any clinically significant activity of chronic medical illness.
- History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
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 |
|---|---|---|
| varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RTvarenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug. | Drug | RT |
| varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TRvarenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug. | Drug | TR |
Primary outcome
AUC
Time frame: 0 (predose) ~ 96 hours
area under the plasma concentration-time curve
Cmax
Time frame: 0 (predose) ~ 96 hours
maximum plasma concentration of the drug
4 secondary outcomes
Tmax
Time frame: 0 (predose) ~ 96 hours
T1/2
Time frame: 0 (predose) ~ 96 hours
CL/F
Time frame: 0 (predose) ~ 96 hours
Vd/F
Time frame: 0 (predose) ~ 96 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 12 Jul 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 varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT and varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR in people with Healthy, run by Korea University Anam Hospital 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 14 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 12 Jul 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?
AUC (time frame: 0 (predose) ~ 96 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 12 Jul 2019.