HealthyPhase 1NCT02529800
Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers
A Phase 1 study testing HIP1402 and HGP0412 in people with Healthy, run by Hanmi Pharmaceutical Company Limited.
Trial summary
To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HIP1402 and HGP0412
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Oct 2015
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer, age 19~50 years
- Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
- Intake of more than 210g of alcohol per week or who can't abstain from alcohol during the trial.
Show all 9Show fewer
- Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
- Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
- Subjects who judged ineligible by the investigator.
About this study
Official title: A Randomized, Open-label, Single Dose, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetics Incorporating a Comparison of Fed/Fasted Pharmacokinetics of HIP1402 in Healthy Male Volunteers
To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition
Read the detailed description
A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers
- Conditions
- Healthy
- Being tested
- HIP1402, HGP0412
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP1402Drug
Tamsulosin HCl 0.4mg
HGP0412Drug
Tamsulosin HCl 0.2mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402 Receives: Drug: HIP1402; Drug: HGP0412 |
| Sequence 2 | Experimental | High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412 Receives: Drug: HIP1402; Drug: HGP0412 |
| Sequence 3 | Experimental | fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402 Receives: Drug: HIP1402; Drug: HGP0412 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tamsulosin, AUC(AUClast, AUCinf),
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Cmax
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Tmax
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, t1/2
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, CL/F
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Vz/F
Measured: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529800
- Sponsor's protocol ID
- HM-VICT-102
- Status last verified
- Oct 2016
- First submitted
- 13 Aug 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ban MS, Kim YK, Kim B, Jung J, Kim YI, Oh J, Yu KS. Evaluation of the pharmacokinetics and food effects of a novel formulation tamsulosin 0.4 mg capsule compared with a 0.2 mg capsule in healthy male volunteers. Transl Clin Pharmacol. 2020 Dec;28(4):181-188. doi: 10.12793/tcp.2020.28.e17. Epub 2020 Nov 24.
PubMed 33425801
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetics Incorporating a Comparison of Fed/Fasted Pharmacokinetics of HIP1402 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02529800
- Acronym / sponsor ID
- HM-VICT-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Aug 2015 (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.
To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition
Detailed description
A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HIP1402, Drug: HGP0412High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402 |
| Sequence 2 | Experimental | Drug: HIP1402, Drug: HGP0412High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412 |
| Sequence 3 | Experimental | Drug: HIP1402, Drug: HGP0412fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteer, age 19~50 years
- Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Key exclusion criteria (9 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
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 |
|---|---|---|
| HIP1402Tamsulosin HCl 0.4mg | Drug | Sequence 1, Sequence 2, Sequence 3 |
| HGP0412Tamsulosin HCl 0.2mg | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Tamsulosin, AUC(AUClast, AUCinf),
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Cmax
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Tmax
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, t1/2
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, CL/F
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Vz/F
Time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
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 13 Oct 2016.
- Derived from this study: PubMed 33425801Ban MS, Kim YK, Kim B, Jung J, Kim YI, Oh J, Yu KS. Evaluation of the pharmacokinetics and food effects of a novel formulation tamsulosin 0.4 mg capsule compared with a 0.2 mg capsule in healthy male volunteers. Transl Clin Pharmacol. 2020 Dec;28(4):181-188. doi: 10.12793/tcp.2020.28.e17. Epub 2020 Nov 24.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Kyung-Sang Yu, M.D. principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIP1402 and HGP0412 in people with Healthy, run by Hanmi Pharmaceutical Company Limited.
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 4 inclusion and 9 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Tamsulosin, AUC(AUClast, AUCinf), (time frame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529800, which also lists 1 linked publication.
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 13 Oct 2016.