PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

• ClinicalTrials.gov Identifier: NCT01829893
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: April 11, 2013
• Sponsor: Korea University Anam Hospital
• Collaborator: GL Pharm Tech Corporation
• Information provided by (Responsible Party): Ji-Young Park, Korea University Anam Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia (BPH)	Drug: In combination of 0.2mg finasteride and 5mg tamsulosin; Drug: GL2701 capsule	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: January 2012
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

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 Name: 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)

Outcome Measures

Primary Outcome Measures :

1. Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC) [ Time Frame: 48 hr ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Korea, Republic of

Clinical trial center of Anam Hospital

Seoul, Korea, Republic of, 136-705

Sponsors and Collaborators

Korea University Anam Hospital

GL Pharm Tech Corporation

Investigators

• Principal Investigator: Ji-Young Park, MD, PhD; Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

More Information

• Responsible Party: Ji-Young Park, Associate Professor, Korea University Anam Hospital
• ClinicalTrials.gov Identifier: NCT01829893
• Other Study ID Numbers: GP-FITAM-104
• First Posted: April 11, 2013
• Last Update Posted: April 11, 2013
• Last Verified: December 2011

Keywords provided by Ji-Young Park, Korea University Anam Hospital:

Benign Prostatic Hyperplasia (BPH); pharmacokinetics; bioequivalence; finasteirde; tamsulosin

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Tamsulosin; Finasteride; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists