Benign Prostatic HyperplasiaPhase 1NCT03887858
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
A Phase 1 study testing Harnal-D Tab. and Chong Kun Dang Tamsulosin HCl Tab. in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Harnal-D Tab. and Chong Kun Dang Tamsulosin HCl Tab.
- 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
- 11 Mar 2019to 7 May 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject older than 19 years men at the screening
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals who had agreed to participate in the study
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- Individuals without mental illness history within five year prior to the screening
- Individuals without a medical history of gastrointestinal operations that may affect drug absorption
- Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration
Who cannot join
- Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
- Individuals who had excessive drinking within the 1 month
- Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
- Individuals who had taken any medication within 10 days prior to the first day of dosing
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
- Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
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- Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
- Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
- Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Individuals with orthostatic hypotension
- Individuals with severe hepatopathy
- Individuals who had taken alpha-1 blocker
- Individuals who had history of micturition syncope
- Individuals with nephropathy
- Elderly person
- Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
- Individuals who had taken CYP3A4 inhibitor
- Individuals who had taken antihypertensive drug(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
Read the detailed description
To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.
Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Harnal-D Tab., Chong Kun Dang Tamsulosin HCl Tab.
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harnal-D Tab.Drug
Harnal-D Tab. 1T single oral administration under fasting
Chong Kun Dang Tamsulosin HCl Tab.Drug
Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Reference/Test | Experimental | 1. Period 1: Harnal-D Tab. 1T
2. Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T Receives: Drug: Harnal-D Tab.; Drug: Chong Kun Dang Tamsulosin HCl Tab. |
| Test/Reference | Experimental | 1. Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T
2. Period 2: Harnal-D Tab. 1T Receives: Drug: Harnal-D Tab.; Drug: Chong Kun Dang Tamsulosin HCl Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Measured: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t
Measured: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start11 Mar 2019
- Primary completion22 Mar 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu-Jung Cha, Principal investigator, Bestian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887858
- Sponsor's protocol ID
- BE117711819/DDS18-029BE
- Status last verified
- Jan 2020
- First submitted
- 21 Mar 2019
- Last updated
- 30 Jan 2020
- 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 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03887858
- Acronym / sponsor ID
- BE117711819/DDS18-029BE
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 25 Mar 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.
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers
Detailed description
To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.
Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference/Test | Experimental | Drug: Harnal-D Tab., Drug: Chong Kun Dang Tamsulosin HCl Tab.1. Period 1: Harnal-D Tab. 1T 2. Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T |
| Test/Reference | Experimental | Drug: Harnal-D Tab., Drug: Chong Kun Dang Tamsulosin HCl Tab.1. Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T 2. Period 2: Harnal-D Tab. 1T |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy subject older than 19 years men at the screening
- Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
- Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
- Individuals who had agreed to participate in the study
Key exclusion criteria (18 listed)
- Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
- Individuals who had excessive drinking within the 1 month
- Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
- Individuals who had taken any medication within 10 days prior to the first day of dosing
- Individuals who were deemed to be inappropriate to participate in the study 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 |
|---|---|---|
| Harnal-D Tab.Harnal-D Tab. 1T single oral administration under fasting | Drug | Reference/Test, Test/Reference |
| Chong Kun Dang Tamsulosin HCl Tab.Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition | Drug | Reference/Test, Test/Reference |
Primary outcome
AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
Time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t
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 30 Jan 2020.
- 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.
Yu-Jung Cha principal investigator
Bestian 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 Harnal-D Tab. and Chong Kun Dang Tamsulosin HCl Tab. in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical 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 9 inclusion and 18 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 30 Jan 2020. 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 of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D (time frame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 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 30 Jan 2020.