CKD-397 Drug-drug Interaction Study (A)

NCT02247518 | Completed Phase 1

• 1 other identifier: 150DDI14012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Male; Volunteers

Outcome Measures

Primary Outcomes (2)

• Tadalafil 5mg AUCt(0-24)

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

• Tadalafil 5mg Cmax

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

Secondary Outcomes (8)

• Tadalafil Css,min

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

• Tadalafil Css,av

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

• Tadalafil Tss,max

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

• Tadalafil t1/2

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

• Tadalafil CL/F

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

Study Arms (2)

Group1: Treatment A + Treatment B, PO

OTHER

Treatment 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.

Drug: Cialis Tab. 5mg; Drug: Harnal-D Cap. 0.2mg

Group2: Treatment B + Treatment A, PO

OTHER

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: Cialis Tab. 5mg; Drug: Harnal-D Cap. 0.2mg

Interventions

Cialis Tab. 5mg DRUG

Also known as: Tadalafil 5mg

Group1: Treatment A + Treatment B, PO; Group2: Treatment B + Treatment A, PO

Harnal-D Cap. 0.2mg DRUG

Also known as: Tamsulosin 0.2mg

Group1: Treatment A + Treatment B, PO; Group2: Treatment B + Treatment A, PO

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Interventions

Tadalafil; Tamsulosin

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Min Gul Kim, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

KR (1)