NCT02239484

Brief Summary

We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both together in a 3 period repeatedly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 4, 2014

Last Update Submit

September 10, 2014

Conditions

Erectile DysfunctionBenign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Tadalafil,Tamsulosin Cmax,ss

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • Tadalafil,Tamsulosin AUCτ

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

Secondary Outcomes (6)

  • Tadalafil,Tamsulosin tmax,ss

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • Tadalafil,Tamsulosin t1/2

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • Tadalafil,Tamsulosin CL/Fss

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • Tadalafil,Tamsulosin Vd/Fss

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • Tadalafil,Tamsulosin Cav

    6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)

  • +1 more secondary outcomes

Study Arms (3)

Sequence 1

EXPERIMENTAL

Tadalafil→Tamsulosin→Tadalafil+Tamsulosin

Drug: TadalafilDrug: TamsulosinDrug: Tadalafil + Tamsulosin

Sequence 2

EXPERIMENTAL

Tadalafil+Tamsulosin→Tadalafil→Tamsulosin

Drug: TadalafilDrug: TamsulosinDrug: Tadalafil + Tamsulosin

Sequence 3

EXPERIMENTAL

Tamsulosin→Tadalafil+Tamsulosin→Tadalafil

Drug: TadalafilDrug: TamsulosinDrug: Tadalafil + Tamsulosin

Interventions

TadalafilDRUG
Sequence 1Sequence 2Sequence 3
TamsulosinDRUG
Sequence 1Sequence 2Sequence 3
Tadalafil + TamsulosinDRUG
Sequence 1Sequence 2Sequence 3

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, age 20 to 55 years.
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
  • Systolic blood pressure \<90mmHg or Diastolic blood pressure \< 70 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samgsung Seoul Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Erectile DysfunctionProstatic Hyperplasia

Interventions

TadalafilTamsulosin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersProstatic Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

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

September 4, 2014

First Posted

September 12, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

KR(1)