Status:
COMPLETED
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
Lead Sponsor:
Korea University Anam Hospital
Collaborating Sponsors:
GL Pharm Tech Corporation
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 tamsulos...
Detailed Description
This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01829893
Start Date
January 1 2012
End Date
February 1 2012
Last Update
April 11 2013
Active Locations (1)
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1
Clinical trial center of Anam Hospital
Seoul, South Korea, 136-705