Clinical trial NCT03887858: Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy subject older than 19 years men at the screening
2. 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)
3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

   \* BMI = Weight(kg)/ Height(m)2
5. Individuals who had agreed to participate in the study
6. Individuals without mental illness history within five year prior to the screening
7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption
8. 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:

1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
2. 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)
3. Individuals who had taken any medication within 10 days prior to the first day of dosing
4. Individuals who were deemed to be inappropriate to participate in the study by the investigator
5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
6. 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)
7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
9. Individuals with orthostatic hypotension
10. Individuals with severe hepatopathy
11. Individuals who had taken alpha-1 blocker
12. Individuals who had history of micturition syncope
13. Individuals with nephropathy
14. Elderly person
15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
16. Individuals who had taken CYP3A4 inhibitor
17. Individuals who had taken antihypertensive drug(s)

Primary outcomes:
measure: AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
timeFrame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
measure: Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D
timeFrame: Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Osong
country: Korea, Republic of
facility: Bestian Hospital
Study officials:
affiliation: Bestian Hospital
name: Yu-Jung Cha
role: PRINCIPAL_INVESTIGATOR
References: