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HealthyPhase 1CKD-397DDI(A)NCT02247518

CKD-397 Drug-drug Interaction Study (A)

A Phase 1 study testing Cialis Tab. 5mg and Harnal-D Cap. 0.2mg in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic properties of tadalafil Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Cialis Tab. 5mg and Harnal-D Cap. 0.2mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSouth Korea
Study dates
Sep 2014to Dec 2014
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy man age 19 years or more and less than 55 years old at the time of screening.
  • BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
  • Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
  • Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
  • Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
  • Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

Who cannot join

  • Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
  • Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
  • Showing the value that corresponds to following laboratory parameters: AST or AST > 2* upper limit of normal range.
  • Alcohol > 210g/week, within 6 months prior to the screening.
  • Taking the medication involved in other clinical trials within two months before the first dose medication characters.
  • Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
Show all 23Show fewer
  • History of alcohol or drug abuse, within 1 year
  • Positive result in urine drug test(Amphetamines, Cocaine, Opioid, Benzodiazepines, Cannabinoid)
  • Positive result in Serology test(Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus), TPPA(qual)).
  • Subject who takes an abnormal meal which can affect the ADME of drug.
  • Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
  • Smoker (> 20cigarettes/day)
  • Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
  • Subject who done the whole blood donation within two months or component blood donation within 1 month prior to the first dosing.
  • Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
  • Subject with taking any forms of organic nitrate periodically and/or intermittently.
  • Subject with known hereditary degenerative retinal disease including retinitis pigmentosa.
  • Subject with serious history of hypersensitivity or allergy to investigational product.
  • Subject who Lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy (NAION).
  • Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
  • Orthostatic hypotension
  • Subjects who is not able to comply with guidelines described in the protocol.
  • Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonbuk National University Hospital

    Jeonju

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tamsulosin on Tadalafil in Healthy Male Volunteers

The purpose of this study is to investigate to effect of tamsulosin on the pharmacokinetic properties of tadalafil

Read the detailed description

This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tamsulosin(0.2mg) on tadalafil(5mg) in healthy male subjects. Subjects will receive repeated dose of tadalafil (5mg*1t/day) or tadalafil (5mg*1t/day) / tamsulosin (0.2mg*1t/day) for 5days. Each treatment period was separated by a washout period of at least 10 days.

Each period of study will enroll 8 healthy male subjects. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events.

Conditions
Healthy
Being tested
Cialis Tab. 5mg, Harnal-D Cap. 0.2mg
Keywords
Male, Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cialis Tab. 5mgDrug

    Also called Tadalafil 5mg

  • Harnal-D Cap. 0.2mgDrug

    Also called Tamsulosin 0.2mg

Study groups in NCT02247518
Study groupRoleWhat they receive
Group1: Treatment A + Treatment B, POOtherTreatment A : Tadarafil 5mg*1t/day for 5days, Treatment B : Tadarafil 5mg*1t/day and Tamsulosin 0.2mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
Receives: Drug: Cialis Tab. 5mg; Drug: Harnal-D Cap. 0.2mg
Group2: Treatment B + Treatment A, POOtherTreatment A : Tamsulosin 0.2mg*1t for 5days, Treatment B : Tamsulosin 0.2mg*1t/day and Tadalafil 5mg*1t/day for 5days, Each treatment period was separated by a washout period of at least 10 days.
Receives: Drug: Cialis Tab. 5mg; Drug: Harnal-D Cap. 0.2mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tadalafil 5mg AUCt(0-24)

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  2. Tadalafil 5mg Cmax

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

Secondary outcomes (8)

  1. Tadalafil Css,min

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  2. Tadalafil Css,av

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  3. Tadalafil Tss,max

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  4. Tadalafil t1/2

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  5. Tadalafil CL/F

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  6. Tadalafil Vd/F

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  7. Tadalafil fluctuation[(Css,max-Css,min)/Css,av]

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

  8. Tadalafil swing[(Css,max-Css,min)/Css,min]

    Measured: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247518
Sponsor's protocol ID
150DDI14012
Acronym
CKD-397DDI(A)
Status last verified
Aug 2015
First submitted
15 Sep 2014
Last updated
20 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cialis Tab. 5mg and Harnal-D Cap. 0.2mg in people with Healthy, 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 6 inclusion and 23 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 20 Aug 2015. 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?

Tadalafil 5mg AUCt(0-24) (time frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h). 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?

On the ClinicalTrials.gov record for NCT02247518.

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 20 Aug 2015.

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CKD-397 Drug-drug Interaction Study (A) (NCT02247518) | AzTrials