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

NCT03887858 | Completed Phase 1

• 1 other identifier: BE117711819/DDS18-029BE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Reference/Test

EXPERIMENTAL

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

Drug: Harnal-D Tab.; Drug: Chong Kun Dang Tamsulosin HCl Tab.

Test/Reference

EXPERIMENTAL

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

Drug: Harnal-D Tab.; Drug: Chong Kun Dang Tamsulosin HCl Tab.

Interventions

Harnal-D Tab. DRUG

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

Reference/Test; Test/Reference

Chong Kun Dang Tamsulosin HCl Tab. DRUG

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

Reference/Test; Test/Reference

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Bestian Hospital

Osŏng, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yu-Jung Cha

  Bestian 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: March 21, 2019
• First Posted: March 25, 2019
• Study Start: March 11, 2019
• Primary Completion: March 22, 2019
• Study Completion: May 7, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)