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Jalyn (Dutasteride / Tamsulosin Hydrochloride) - Summary

 
 



JALYN SUMMARY

JALYN (dutasteride and tamsulosin hydrochloride) Capsules contain dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT) and tamsulosin (an antagonist of alpha1A-adrenoceptors in the prostate).

Benign Prostatic Hyperplasia (BPH) Treatment

JALYN™ (dutasteride and tamsulosin hydrochloride) Capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Limitations of Use

Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.


See all Jalyn indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Jalyn (Dutasteride / Tamsulosin)

Benign Prostatic Hyperplasia
Source: MedicineNet Blood In Urine Specialty [2015.05.19]
Title: Benign Prostatic Hyperplasia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/19/2015 12:00:00 AM

Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Source: MedicineNet Prostatitis Specialty [2012.02.29]
Title: Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Category: MedicineNet Quiz
Created: 2/7/2012 3:29:00 PM
Last Editorial Review: 2/29/2012 6:25:09 PM

more news >>

Clinical Trials Related to Jalyn (Dutasteride / Tamsulosin)

JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) [Terminated]
Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part related to prostate enlargement and obstruction. The standard medical therapy

for this condition includes 5-alpha reductase inhibitors - 5ARI (eg dutasteride) or alpha

blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ specific phenotype) is the third most prevalent prostate disease after prostate cancer and BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of life of patients and economic costs to society. Clinical phenotyping allows for prediction of the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg. BPH and CP/CPPS).

Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States [Completed]
This study will be an open-label, randomized, single dose, three way crossover study in healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0. 5 milligram [mg]/0. 2 mg) relative to co-administration of dutasteride 0. 5 mg capsules and tamsulosin hydrochloride 0. 2 mg tablets in both the fed and fasted states. Approximately 84 healthy adult male subjects will be enrolled into the study and split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment periods and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) wherein A= FDC1: Dutasteride and tamsulosin HCl (0. 5 mg/0. 2 mg), B= FDC2: Dutasteride and tamsulosin HCl (0. 5 mg/0. 2 mg), C= Co-administration of commercial formulations of dutasteride(0. 5mg) and tamsulosin HCl (0. 2mg). Each treatment period will be separated by a minimum 28 day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate and review of adverse events.

Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects [Not yet recruiting]
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0. 5 milligram [mg]/0. 2 mg) relative to coadministration of one dutasteride 0. 5 mg capsule and one tamsulosin HCl 0. 2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0. 5 mg/tamsulosin HCl 0. 2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i. e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2. 5 months from screening to the final follow-up visit.

A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. [Completed]
This study will be an open-label, randomized, single dose, two-period crossover study to determine the bioavailability of a fixed dose combination capsule formulation of dutasteride and tamsulosin hydrochloride (0. 5mg/0. 2mg) relative to co-administration of dutasteride 0. 5mg capsules and tamsulosin hydrochloride 0. 2mg tablets in healthy male subjects of North East Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination capsule formulation of dutasteride 0. 5 mg/ tamsulosin 0. 2 mg in a fed or fasted state or concomitant dosing of dutasteride 0. 5 mg and the Japan-sourced Harnal-D 0. 2 mg in a fed or fasted state. Each dose of study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events. The study will enrol 88 healthy male subjects to ensure that 80 complete the study. At least twenty percent of the study population will be of Japanese ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of Korean ancestry while the remainder of the population will be of non-Asian ancestry.

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State [Completed]
The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0. 5 milligram (mg) and tamsulosin HCL 0. 4 mg capsule in healthy adult male subjects. Subjects in this study will receive either a single oral dose of the second generation dutasteride 0. 5 mg and tamsulosin 0. 4 mg combination capsule or a single dose of commercially available combination of dutasteride 0. 5 mg and tamsulosin HCL 0. 4 mg followed by a 28-day washout period both in fasted state. The study will enroll approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable subjects. The total duration of a subject's involvement in this study is anticipated to be approximately 12 weeks.

more trials >>

Reports of Suspected Jalyn (Dutasteride / Tamsulosin) Side Effects

Drug Ineffective (17)Dizziness (17)Rash (10)Erectile Dysfunction (9)Headache (7)Nocturia (6)Gynaecomastia (6)Oedema Peripheral (6)Dyspnoea (6)Libido Decreased (6)more >>


Page last updated: 2015-05-19

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