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PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

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

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.

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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

Resource links provided by the National Library of Medicine


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)




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829893


Locations
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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
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Principal Investigator: Ji-Young Park, MD, PhD Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
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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    Key Record Dates
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:
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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