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CKD-397 Drug-drug Interaction Study (B) (CKD-397DDI(B))

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ClinicalTrials.gov Identifier: NCT02247505
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic properies of tamsulosin

Condition or disease Intervention/treatment Phase
Healty Male Volunteers Drug: Harnal-D Cap. 0.2mg Drug: Cialis Tab. 5mg Phase 1

Detailed Description:
This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects Subjects will receive repeated dose of tamsulosin (0.2mg*1t/day) or tamsulosin (0.2mg*1t/day) / tadalafil (5mg*1t/day) for 5days Each treatment period was separated by a washout period of at least 10 days. Each period of study will enroll 14 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Pharmacokinetic Effect of Tadalafil on Tamsulosin in Healthy Male Volunteers
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group1: Treatment A + Treatment B, PO
Treatment 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.
Drug: Harnal-D Cap. 0.2mg
Other Name: Tamsulosin 0.2mg

Drug: Cialis Tab. 5mg
Other Name: Tadalafil 5mg

Group2: Treatment B + Treatment A, PO
Treatment 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.
Drug: Harnal-D Cap. 0.2mg
Other Name: Tamsulosin 0.2mg

Drug: Cialis Tab. 5mg
Other Name: Tadalafil 5mg




Primary Outcome Measures :
  1. Tamsulosin AUCt(0-24) [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  2. Tamsulosin Cmax [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]

Secondary Outcome Measures :
  1. Tamsulosin Css,min [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  2. Tamsulosin Css,av [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  3. Tamsulosin Tss,max [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  4. Tamsulosin t1/2 [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  5. Tamsulosin CL/F [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  6. Tamsulosin Vd/F [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  7. Tamsulosin fluctuation[(Css,max-Css,min)/Css,av] [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]
  8. Tamsulosin swing[(Css,max-Css,min)/Css,min] [ Time Frame: 1D 0h, 3D 0h, 4D 0h, 5D 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247505


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju-si, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Min Gul Kim, PhD Chonbuk National University Hospital

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02247505     History of Changes
Other Study ID Numbers: 150DDI14013
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Tadalafil
Tamsulosin
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs