Bioequivalence - Duodart Against Avodart & Omnic

NCT01657851 | Completed Phase 1

• 1 other identifier: 116502
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, randomized, single dose, two-treatment, two-way crossover study

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• bioequivalence of a Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg (Duodart® 0.5 mg/ 0.4 mg fixed combination) relative to concomitant dosing of Avodart® 0.5 mg and the Omnic® 0.4

  Dutasteride and tamsulosin will be extracted from human plasma by liquid-liquid extraction using organic solvent. Extracts will be analysed by validated high-performance liquid chromatography - mass spectrometry. The lower limit of detection is about 0.1ng/mL

  2 months

Secondary Outcomes (1)

• to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg

  2 months

Study Arms (3)

dutasteride/tamsulosin

EXPERIMENTAL

The present study is planned to establish bioequivalence of Duodart® 0.5mg/0.4mg manufactured by GlaxoSmithKline to concomitant dosing with separate capsules of dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg formulations commercially available in Russia.

Drug: dutasteride/tamsulosin

dutasteride

ACTIVE COMPARATOR

Dutasteride (Avodart®) is an approved potent dual type I and II, 5-alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery.

Drug: dutasteride; Drug: tamsulosin

tamsulosin

ACTIVE COMPARATOR

Tamsulosin (Omnic®) is an alpha-1A-adrenocepter blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia

Drug: dutasteride; Drug: tamsulosin

Interventions

dutasteride/tamsulosin DRUG

Duodart® 0.5 mg / 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

Also known as: Duodart® 0.5 mg / 0.4 mg

dutasteride/tamsulosin

dutasteride DRUG

Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

Also known as: Avodart® 0.5 mg

dutasteride; tamsulosin

tamsulosin DRUG

Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules

Also known as: Omnic® 0.4 mg

dutasteride; tamsulosin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give written informed consent
• Males who are 18 - 45 years of age, inclusive
• Verified diagnosis "healthy"
• Body mass index 20-25 kg/m2 (inclusive)
• Negative results of test for HIV, syphilis, hepatitis B (HBs Ag) and hepatitis C
• Adequate, liver, and renal function
• adequate contraception

You may not qualify if:

• Poor metabolizer for CYP2D6
• Medical history of allergy
• Medical history of medicines intolerability
• Chronic diseases
• History of surgery on gastrointestinal tract
• History of prostate cancer
• History of breast cancer
• Acute infectious disease
• Regular use of drugs
• Intake of medicines with high influence on liver function or haemodynamics
• Use of drugs that influence activity of CYP2D6 and CYP3A4
• Use of Dutasteride less than 6 months before study entry or alpha-blockers less than 2 weeks before study entry
• Blood donation (≥450 mL of blood or plasma) less than 2 months before study start
• History of regular alcohol consumption
• A positive urine drug or alcohol

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Reutov, Moscow Region, 143964, Russia

Location

Related Links

• Results for study 116502 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: August 23, 2012
• Primary Completion: December 5, 2012
• Study Completion: December 5, 2012
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

RU (1)