NCT01829893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

April 11, 2013

Status Verified

December 1, 2011

Enrollment Period

1 month

First QC Date

April 8, 2013

Last Update Submit

April 8, 2013

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Benign Prostatic Hyperplasia (BPH)pharmacokineticsbioequivalencefinasteirdetamsulosin

Outcome Measures

Primary Outcomes (1)

  • Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC)

    48 hr

Study Arms (2)

Reference arm

ACTIVE COMPARATOR

Treated with Reference (in combination of 0.2mg tamsulosin and 5mg finasteride) Intervetion: In combination of 0.2mg finasteride and 5mg tamsulosin simultaneously

Drug: In combination of 0.2mg finasteride and 5mg tamsulosin

Test arm

EXPERIMENTAL

Treated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule

Drug: GL2701 capsule

Interventions

In combination of 0.2mg finasteride and 5mg tamsulosinDRUG

oral medication with 240 mL water

Also known as: GL2701 capsule
Reference arm
GL2701 capsuleDRUG

oral medication with 240 mL water

Also known as: Harunal-D (tamsulosin 0.2mg), Prosca (Finasteride 5 mg)
Test arm

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males age 20 to 45 years
  • Body weight \> 50 kg with 18\~29 kg/m2 body mass index (BMI)
  • Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

You may not qualify if:

  • subjects with acute conditions.
  • presence of history affecting ADME
  • Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
  • Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
  • Any other acute or chronic disease
  • A history of hypersensitivity to donepezil
  • A history of alcohol or drug abuse
  • Participation in another clinical trial within 3 months
  • smoked \>10 cigarettes daily
  • consumption over 5 glasses daily of beverages containing xanthine derivatives
  • use of any medication having the potential to affect the study results within 10 days before the start of the study.
  • AST or ALT \> 1.25 of upper normal limit
  • total bilirubin \> 1.5 of upper normal limit
  • systolic blood pressure \< 90 mmHg
  • calculated CLcr using Cockroft-Gault equation \< 50 mL/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical trial center of Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

FinasterideTamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, HeterocyclicBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Ji-Young Park, MD, PhD

    Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 11, 2013

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 11, 2013

Record last verified: 2011-12

Locations

KR(1)