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.
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NEWS HIGHLIGHTSMedia Articles Related to Jalyn (Dutasteride / Tamsulosin)
Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Source: MedicineNet Benign Prostatic Hyperplasia Specialty [2017.09.20]
Title: Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Category: MedicineNet Quiz
Created: 2/7/2012 3:29:00 PM
Last Editorial Review: 9/20/2017 12:17:12 PM
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Source: MedicineNet Blood In Urine Specialty [2017.05.18]
Title: Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/18/2017 12:00:00 AM
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.
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 >>
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Page last updated: 2017-09-20
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