PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829893
• Other study ID #: GP-FITAM-104
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2013
• Last updated: April 8, 2013
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: December 2011
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• In combination of 0.2mg finasteride and 5mg tamsulosin
oral medication with 240 mL water
• GL2701 capsule
oral medication with 240 mL water

Locations

Country	Name	City	State
Korea, Republic of	Clinical trial center of Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	GL Pharm Tech Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC)		48 hr	No