NCT01829893

PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

Open Label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics Between Coadministered Finasteride Tablet and Tamsulosin HCl Tablet and GL2701 Capsule, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

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 of a newly developed formulation with a conventional formulation in healthy subjects. For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. Participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. Plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.

Conditions

• Benign Prostatic Hyperplasia (BPH)

Interventions

Type	Name	Description
DRUG	In combination of 0.2mg finasteride and 5mg tamsulosin	oral medication with 240 mL water
DRUG	GL2701 capsule	oral medication with 240 mL water

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2013-04-11
• Last updated: 2013-04-11

Locations

1 site across 1 country: South Korea