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Safety and Pharmacokinetic Characteristics of DKF-313

NCT02352311 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-07-06

No results posted yet for this study

Summary

This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.

Conditions

  • Benign Prostate Hyperplasia
  • Healthy

Interventions

DRUG

DKF-313

Combination of dutasteride 0.5 mg and tadalafil 5 mg

DRUG

AVODART

Dutasteride 0.5 mg

DRUG

CIALIS

Tadalafil 5 mg

Sponsors & Collaborators

  • Dongkook Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Min-Gul Kim, M.D. · Chonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02352311 on ClinicalTrials.gov