PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

NCT ID: NCT01829893

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-02-29

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 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Reference arm

Treated with Reference (in combination of 0.2mg tamsulosin and 5mg finasteride) Intervetion: In combination of 0.2mg finasteride and 5mg tamsulosin simultaneously

Group Type: ACTIVE_COMPARATOR

In combination of 0.2mg finasteride and 5mg tamsulosin

Intervention Type: DRUG

oral medication with 240 mL water

Test arm

Treated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule

Group Type: EXPERIMENTAL

GL2701 capsule

Intervention Type: DRUG

oral medication with 240 mL water

Interventions

In combination of 0.2mg finasteride and 5mg tamsulosin

oral medication with 240 mL water

Intervention Type: DRUG

GL2701 capsule

oral medication with 240 mL water

Intervention Type: DRUG

Other Intervention Names

GL2701 capsule; Harunal-D (tamsulosin 0.2mg); Prosca (Finasteride 5 mg)

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GL Pharm Tech Corporation

INDUSTRY

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Young Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji-Young Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Locations

Clinical trial center of Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GP-FITAM-104

Identifier Type: -

Identifier Source: org_study_id