Trial | NCT03887871  Report issue

Title

Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal
An Open-label, Randomized, Fed, 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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
This study is an open-label, randomized, fed, 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
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 Started
Mar 11
2019
Primary Completion
Mar 22
2019
Study Completion
Apr 23
2019
Last Update
Jan 30
2020

Drug Harnal-D Tab.

Harnal-D Tab. 1T single oral administration after meal

Drug Chong Kun Dang Tamsulosin HCl Tab.

Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration after meal

Reference/Test Experimental

Period 1: Harnal-D Tab. 1T Period 2: Chong Kun Dang Tamsulosin HCl Tab. 1T

Test/Reference Experimental

Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T Period 2: Harnal-D Tab. 1T

Criteria 

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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)
No Results Posted