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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Drug: In combination of 0.2mg finasteride and 5mg tamsulosin; Drug: GL2701 capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • Clinical trial center of Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: In combination of 0.2mg finasteride and 5mg tamsulosin; oral medication with 240 mL water; Other Names: GL2701 capsule
Experimental: Test arm; Treated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule	Drug: GL2701 capsule; oral medication with 240 mL water; Other Names: Harunal-D (tamsulosin 0.2mg); Prosca (Finasteride 5 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC)	48 hr

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: GL Pharm Tech Corporation
• Investigators: Principal Investigator: Ji-Young Park, MD, PhD, Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 11, 2013

Study Record Updates

• Last Update Posted (Estimate): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); pharmacokinetics; bioequivalence; tamsulosin; finasteirde
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Tamsulosin; Finasteride
• Other Study ID Numbers: GP-FITAM-104