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

NCT ID: NCT03887858

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2019-05-07

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference/Test

1. Period 1: Harnal-D Tab. 1T

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

Group Type: EXPERIMENTAL

Harnal-D Tab.

Intervention Type: DRUG

Harnal-D Tab. 1T single oral administration under fasting

Chong Kun Dang Tamsulosin HCl Tab.

Intervention Type: DRUG

Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition

Test/Reference

1. Period 1: Chong Kun Dang Tamsulosin HCl Tab. 1T

2. Period 2: Harnal-D Tab. 1T

Group Type: EXPERIMENTAL

Harnal-D Tab.

Intervention Type: DRUG

Harnal-D Tab. 1T single oral administration under fasting

Chong Kun Dang Tamsulosin HCl Tab.

Intervention Type: DRUG

Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition

Interventions

Harnal-D Tab.

Harnal-D Tab. 1T single oral administration under fasting

Intervention Type: DRUG

Chong Kun Dang Tamsulosin HCl Tab.

Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition

Intervention Type: DRUG

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Jung Cha

Role: PRINCIPAL_INVESTIGATOR

Bestian Hospital

Locations

Bestian Hospital

Osŏng, , South Korea

Countries

South Korea

Other Identifiers

BE117711819/DDS18-029BE

Identifier Type: -

Identifier Source: org_study_id