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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

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC) [ Time Frame: 48 hr ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
Official Title  ICMJE Open Label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics Between Coadministered Finasteride Tablet and Tamsulosin HCl Tablet and GL2701 Capsule, in Healthy Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Benign Prostatic Hyperplasia (BPH)
Intervention  ICMJE
  • Drug: In combination of 0.2mg finasteride and 5mg tamsulosin
    oral medication with 240 mL water
    Other Name: GL2701 capsule
  • Drug: GL2701 capsule
    oral medication with 240 mL water
    Other Names:
    • Harunal-D (tamsulosin 0.2mg)
    • Prosca (Finasteride 5 mg)
Study Arms  ICMJE
  • 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
    Intervention: Drug: In combination of 0.2mg finasteride and 5mg tamsulosin
  • Experimental: Test arm
    Treated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule
    Intervention: Drug: GL2701 capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829893
Other Study ID Numbers  ICMJE GP-FITAM-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji-Young Park, Korea University Anam Hospital
Study Sponsor  ICMJE Korea University Anam Hospital
Collaborators  ICMJE GL Pharm Tech Corporation
Investigators  ICMJE
Principal Investigator: Ji-Young Park, MD, PhD Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
PRS Account Korea University Anam Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP