NCT01942551CompletedPhase 1
Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride
Dongkook Pharmaceutical Co., Ltd.1 site in 1 country47 target enrollmentStarted: September 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Area Under Curve (AUC) of tadalafil
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 29 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 20 to 29 years
- •Weight 60 kg or more, within 20% of Ideal body weight
- •No congenital or chronic diseases, no disease symptoms or findings
- •Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
- •Voluntarily signed the informed consent form
Exclusion Criteria
- •Clinically significant disorders of hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
- •Gastrointestinal diseases or surgery which may affect absorption of the investigational products
- •hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor
- •Lactose intolerance
- •SBP ≥ 140 mmHg or < 90 mmHg or DBP ≥ 95 mmHg or < 60 mmHg
- •Serum creatinine > ULN
- •History or positive result of drug abuse
- •Drugs which induce or inhibit drug metabolism including barbiturates within 1 month
- •Prescribed drugs or herbal medicines within 2 weeks, or over-the counter drugs or vitamins within 1 week
- •CYP3A4 inhibitors or CYP3A4 inducers within 2 weeks
- •Food including grapefruit from Week -1 to final dose
- •Participated and administered the investigational products in other clinical trial within 2 months
- •Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
- •Plans to donate blood for at least 6 months after final dose of dutasteride
- •Scheduled dental treatment and elective surgery from informed consent to post-study visit
- •Excessive alcohol consumption (> 21 units/week, 1 unit = 10 g of pure alcohol)
- •Smoked more than 10 cigarettes a day for past 3 months
- •Not eligible due to other reasons including laboratory results
Arms & Interventions
dutasteride, tadalafil
Experimental
Intervention: Dutasteride (Drug)
tadalafil, dutasteride
Experimental
Intervention: Tadalafil (Drug)
tadalafil, dutasteride
Experimental
Intervention: Dutasteride (Drug)
dutasteride, tadalafil
Experimental
Intervention: Tadalafil (Drug)
Outcomes
Primary Outcomes
Area Under Curve (AUC) of tadalafil
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 h
Cmax of tadalafil
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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