Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887858
• Other study ID #: BE117711819/DDS18-029BE
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2019
• Est. completion date: May 7, 2019

Study information

• Verified date: January 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 7, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Harnal-D Tab.
Harnal-D Tab. 1T single oral administration under fasting
• Chong Kun Dang Tamsulosin HCl Tab.
Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition

Locations

Country	Name	City	State
Korea, Republic of	Bestian Hospital	Osong

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D	Area under the Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood-time curve from zero to final	Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours
Primary	Cmax of Chong Kun Dang Tamsulosin HCl Tablet and Harnal-D	The maximum Chong Kun Dang Tamsulosin HCl Tablet / Harnal-D concentration in blood sampling time t	Pre-dose (0 hour), post-dose 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hours