PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Male

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 tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborator: GL Pharm Tech Corporation
• Treatments: Finasteride; Tamsulosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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