A Randomized, Open-label, Single-dose, 2-treatment, 2-way, 2-period Crossover Study to Evaluate the Safety and the Pharmacokinetic Characteristics of DKF-313 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AVODART
- Conditions
- Benign Prostate Hyperplasia
- Sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- AUClast and Cmax of dutasteride and tadalafil
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and tadalafil) in healthy male volunteers.
Detailed Description
This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy male volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 19 to 29 years
- •BMI 17.5 to 30.5 kg/m2 and body weight 55 kg or more
- •No congenital or chronic diseases within 3 years, no disease symptoms or findings
- •Eligible according to the laboratory results of hematology, blood chemistry and urinalysis and ECG
- •Voluntarily signed the informed consent form
- •Willing to participate in the study
Exclusion Criteria
- •Clinically significant disorders of blood, kidney, endocrine, respiratory system, gastrointestinal system, urology, cardiovascular system, liver, psychiatry, neurology or allergy
- •Gastrointestinal diseases or surgery which may affect absorption of the investigational products
- •ALT or AST \> 2xULN
- •Excessive alcohol consumption (\> 210 g/week) within 6 months
- •Participated and administered the investigational products in other clinical trial within 2 months
- •SBP ≤ 100 mmHg or ≥ 150 mmHg or DBP ≤ 60 mmHg or ≥ 100 mmHg
- •History or positive result of serious alcohol or drug abuse within 1 year
- •Drugs which induce or inhibit drug metabolism within 1 month
- •Smoked more than 10 cigarettes a day
- •Prescribed drugs or over-the counter drugs within 10 days
Arms & Interventions
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
Intervention: AVODART
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
Intervention: DKF-313
Arm 1 AVODART, CIALIS, DKF-313
In Period 1, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose. In Period 2, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose.
Intervention: CIALIS
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
Intervention: DKF-313
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
Intervention: AVODART
Arm 2 DKF-313, AVODART, CIALIS
In Period 1, DKF-313 tablet (dutasteride 0.5 mg and tadalafil 5 mg) is administered as single dose. In Period 2, AVODART (dutasteride) soft gelatin capsule and CIALIS (tadalafil) tablet 5 mg are administered as single dose.
Intervention: CIALIS
Outcomes
Primary Outcomes
AUClast and Cmax of dutasteride and tadalafil
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192 h