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PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

NCT01829893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-04-11

No results posted yet for this study

Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DRUG

In combination of 0.2mg finasteride and 5mg tamsulosin

oral medication with 240 mL water

DRUG

GL2701 capsule

oral medication with 240 mL water

Sponsors & Collaborators

  • GL Pharm Tech Corporation

    collaborator INDUSTRY

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Ji-Young Park, MD, PhD · Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

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 NCT01829893 on ClinicalTrials.gov