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NCT02578953
Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Phase 1 trial testing Dutasteride-Test product in Prostatic Hyperplasia in 36 participants. Completed in 15 December 2015.
15 December 2015
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 9 September 2015 |
| Primary completion | 15 December 2015 |
| Estimated completion | 15 December 2015 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Dutasteride-Test product — full drug profile →
- Dutasteride-Reference product — full drug profile →
Conditions studied
- Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 20 to 64, male only, with Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02578953
- Europe PMC full search
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Related trials
Other trials of Dutasteride-Test product
Trials testing the same drug.
- NCT06233227 — Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule · Phase 1 · unknown
Other recruiting trials for Prostatic Hyperplasia
Currently open trials in the same condition.
- NCT06242119 — Clinical Application of the J-PET Scanner Prototype · recruiting
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- NCT06209307 — Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate · NA · active not recruiting
- NCT06001619 — Prostate Medication, Metabolism and Gut Microbiota · Phase 4 · recruiting
- NCT03354416 — Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02578953 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 19 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02578953.
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