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

NCT03887858 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-30

No results posted yet for this study

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

Interventions

DRUG

Harnal-D Tab.

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

DRUG

Chong Kun Dang Tamsulosin HCl Tab.

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

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Yu-Jung Cha · Bestian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2019-03-22
Completion
2019-05-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887858 on ClinicalTrials.gov