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.

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.

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

Prostatic Hyperplasia

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

dutasteride/tamsulosin

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

dutasteride

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

tamsulosin

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

GSK Investigational Site

Bioequivalence - Duodart Against Avodart & Omnic

An Open-Label, Randomized, Single Dose Crossover Study to Determine the Bioequivalence of Duodart® 0.5mg/0.4mg (Capsule Formulation of Dutasteride 0.5mg and Tamsulosin Hydrochloride 0.4mg) Compared to Concomitant Dosing of Avodart® 0.5mg and Omnic® 0.4mg Commercial Capsules in Healthy Male Subjects.

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

The following safety parameters will be assessed during the study: Physical examination; Orthostatic vital signs; Vital signs; 12-lead ECG; Adverse events; Serum chemistry; Complete blood count

dizziness/зеле

Bioequivalence - Duodart Against Avodart & Omnic

Най-пълната база данни за лечебни билки, подкрепена от науката