NCT01942551

Brief Summary

This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of tadalafil and dutasteride in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

September 11, 2013

Last Update Submit

January 22, 2015

Conditions

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (4)

  • Area Under Curve (AUC) of tadalafil

    0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h

  • Cmax of tadalafil

    0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h

  • Area Under Curve (AUC) of dutasteride

    0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48, 72, 96, 144, 192, 240, 288, 336 h

  • Cmax of dutasteride

    0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48, 72, 96, 144, 192, 240, 288, 336 h

Study Arms (2)

tadalafil, dutasteride

EXPERIMENTAL
Drug: TadalafilDrug: Dutasteride

dutasteride, tadalafil

EXPERIMENTAL
Drug: TadalafilDrug: Dutasteride

Interventions

TadalafilDRUG
dutasteride, tadalafiltadalafil, dutasteride
DutasterideDRUG
dutasteride, tadalafiltadalafil, dutasteride

Eligibility Criteria

Age20 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age 20 to 29 years 2. Weight 60 kg or more, within 20% of Ideal body weight 3. No congenital or chronic diseases, no disease symptoms or findings 4. Eligible according to the laboratory results of hematology, blood chemistry and urinalysis 5. Voluntarily signed the informed consent form

You may not qualify if:

  • \. Clinically significant disorders of hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system 2. Gastrointestinal diseases or surgery which may affect absorption of the investigational products 3. hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor 4. Lactose intolerance 5. SBP ≥ 140 mmHg or \< 90 mmHg or DBP ≥ 95 mmHg or \< 60 mmHg 6. Serum creatinine \> ULN 7. History or positive result of drug abuse 8. Drugs which induce or inhibit drug metabolism including barbiturates within 1 month 9. Prescribed drugs or herbal medicines within 2 weeks, or over-the counter drugs or vitamins within 1 week 10. CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks 11. Food including grapefruit from Week -1 to final dose 12. Participated and administered the investigational products in other clinical trial within 2 months 13. Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month 14. Plans to donate blood for at least 6 months after final dose of dutasteride 15. Scheduled dental treatment and elective surgery from informed consent to post-study visit 16. Excessive alcohol consumption (\> 21 units/week, 1 unit = 10 g of pure alcohol) 17. Smoked more than 10 cigarettes a day for past 3 months 18. Not eligible due to other reasons including laboratory results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

TadalafilDutasteride

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingAzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

KR(1)