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Trial record 78 of 117 for:    DUTASTERIDE

A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State

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ClinicalTrials.gov Identifier: NCT00537654
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 28, 2007
First Posted Date  ICMJE October 1, 2007
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE October 18, 2007
Actual Primary Completion Date February 22, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Concentration maximum (Cmax) of plasma tamsulosin in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Concentration maximum (Cmax) of plasma dutasteride in fed state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Concentration maximum (Cmax) of plasma tamsulosin in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Concentration maximum (Cmax) of plasma dutasteride in fasted state [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2007)
PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72 [ Time Frame: PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72 ]
Change History Complete list of historical versions of study NCT00537654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Concentration minimum (Cmax) of plasma tamsulosin [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Time to maximum observed plasma drug concentration (tmax) of tamsulosin and dutasteride [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Elimination half-life (t1/2) of tamsulosin and dutasteride [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Negative slope of the terminal phase of tamsulosin and dutasteride [ Time Frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs ]
    Plasma samples will be collected at indicated time points
  • Number of subjects with adverse event (AE) and serious adverse event (SAE). [ Time Frame: Up to 18 weeks ]
    AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.
  • Number of subjects with abnormal clinical laboratory parameters [ Time Frame: Up to 18 weeks ]
    Blood samples will be collected to analyze aspartate aminotransferase (AST), alkaline Phosphatase (ALP), alanine aminotransferase (ALT), creatinine, blood urea nitrogen, creatine kinase, total bilirubin, direct bilirubin, total protein, albumin, glucose, sodium, potassium, calcium
  • Number of subjects with abnormal hematology laboratory parameters [ Time Frame: Up to 18 weeks ]
    Blood samples will be collected to analyze White Blood Cells (WBC), neutrophils, basophils, eosionophils, lymphocytes, monocytes, Red Blood Cells (RBC) count, RBC indices, Day -1average red blood cell size (MCV), hemoglobin amount per red blood cell (MCH) hemoglobin, hematocrit, and platelet count
  • Number of subjects with abnormal urinalysis [ Time Frame: Up to 18 weeks ]
    Urine samples will be collected to analyze specific gravity, pH, glucose, protein, blood and ketones
  • Blood pressure assessment as a measure of safety [ Time Frame: Up to 18 weeks ]
    Systolic and diastolic blood pressure will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
  • Measurement of pulse rate as a measure of safety [ Time Frame: Up to 18 weeks ]
    Pulse rate will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2007)
safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Official Title  ICMJE An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART™ 0.5mg and Flomax 0.4mg Commercial Capsules in Healthy Male Subjects
Brief Summary This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
Detailed Description An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: Treatment sequence A
    Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state
  • Drug: Treatment sequence B
    Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state
  • Drug: Treatment sequence C
    Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state
  • Drug: Treatment sequence D
    Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state
Study Arms  ICMJE
  • Experimental: Fasted state
    Subjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days
    Interventions:
    • Drug: Treatment sequence C
    • Drug: Treatment sequence D
  • Experimental: Fed state
    Subjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days
    Interventions:
    • Drug: Treatment sequence A
    • Drug: Treatment sequence B
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 15, 2008)
81
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2007)
78
Actual Study Completion Date  ICMJE February 22, 2008
Actual Primary Completion Date February 22, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy subjects defined as individuals who are free from clinically significant illness or disease as determined by the investigator based on their medical history, physical examination, laboratory studies, ECGs, and other tests.
  • Males who are 18 - 45 years of age, inclusive.
  • Weight range 55 - 95 kg (inclusive) and body mass index 19 - 30 kg/m2 (inclusive).
  • Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures

Exclusion criteria:

  • Slow metabolizer for CYP2D6 as determined by screening PGx analysis.
  • History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Chronic hepatitis B and C, as evidence by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
  • Positive HIV test at screening.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening. Subjects must be able and willing to abstain from beverages and foods containing alcohol 24 hours prior to and during the dosing day.
  • A positive urine drug or alcohol (Breath test or urine) screen result at screening or check-in..
  • The subject has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication or anytime during the study period.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
  • History or presence of allergy, intolerance, or contraindication to tamsulosin HCl or AVODART or drugs of this class, or a history of drug or other allergy (including true sulfonamide allergy) that, in the opinion of the physician responsible, contraindicates their participation.
  • Subjects who have consumed the following foods or drinks within 7 days prior to the first dose of study medication or at any time during the clinical phase of the study: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
  • QTc ≥ 450 msec at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537654
Other Study ID Numbers  ICMJE ARI109882
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

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