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Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects

NCT02578953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-06-19

No results posted yet for this study

Summary

This will be a single center, open-label, single dose, randomized and 2-way crossover study in healthy Japanese male subjects under fasting conditions. The study will be conducted to determine the bioequivalence between dutasteride capsules manufactured at GSK (test product) and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male subjects. Subjects will have a screening visit within 30 days prior to the first dose of study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14 days after the second dose for the first follow-up and a second follow up via telephone 50-54 days after the second dose. The total duration of the study will be approximately 15 weeks from screening to the second follow up.

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

Dutasteride-Test product

Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by GSK, Poznan.

DRUG

Dutasteride-Reference product

Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Glycerin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by Catalent, Beinheim.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-09
Primary Completion
2015-12-15
Completion
2015-12-15

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578953 on ClinicalTrials.gov