Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02058368 | Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia | PHASE3 | COMPLETED | 607 | — | — | Feb 10, 2014 | Mar 3, 2017 | Apr 5, 2019 | 46 | China, Japan +2 |
| NCT00368979 | Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects | PHASE3 | COMPLETED | 378 | — | — | Feb 17, 2006 | Dec 6, 2007 | Sep 26, 2018 | 26 | Japan |
| NCT02509104 | 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 | PHASE1 | COMPLETED | 56 | — | — | Jul 30, 2015 | Oct 10, 2015 | Jun 19, 2018 | 1 | United States |
| NCT01957189 | This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples | PHASE1 | COMPLETED | 24 | — | — | Oct 25, 2013 | Jan 22, 2014 | Jun 19, 2018 | 1 | China |
| NCT01657851 | Bioequivalence - Duodart Against Avodart & Omnic | PHASE1 | COMPLETED | 35 | — | — | Aug 23, 2012 | Dec 5, 2012 | Jun 20, 2017 | 1 | Russia |
| NCT01495026 | A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia | PHASE1 | COMPLETED | 63 | — | — | Nov 6, 2011 | Apr 3, 2012 | Jun 19, 2018 | 1 | Australia |
| NCT01471678 | Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. | PHASE1 | COMPLETED | 27 | — | — | Jun 30, 2011 | Sep 7, 2011 | Jun 19, 2018 | 1 | Australia |
| NCT01577693 | Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects | PHASE1 | COMPLETED | 35 | — | — | May 12, 2011 | Aug 31, 2011 | Jun 19, 2018 | 1 | United States |
IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.
The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. Cmax will be determined for tamsulosin and dutasteride.
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. AUC 0-t will be determined for tamsulosin and dutasteride. Additionally, AUC 0-inf will be determined for tamsulosin as data permit.
Serum dutasteride AUC (0-t), Cmax, tmax, following 0.5mg single dose administration with and without tamsulosin 0.2mg q24h. Serum tamsulosin AUC(0-τ), Cmax, tmax, Cτ and CL/F following 0.2mg q24h administration with and without dutasteride 0.5mg single dose.
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
To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Run-in phase: All subjects qualifying for the study will entered into a placebo run-in phase will receive one soft gelatin placebo capsule (swallowed whole and not chewed) and one oral disintegrating placebo tablet once daily (OD) (dissolved on the tongue then swallowed not chewed), following the first meal each day for four weeks. Randomized treatment phase: Subjects will be instructed to take 1 dutasteride 0.5 milligram (mg) capsule (swallowed whole and not chewed) and one tamsulosin 0.2mg tablet OD (dissolved on the tongue then swallowed not chewed) following the first meal each day for 104 weeks. |
| Arm 2 | EXPERIMENTAL | Run-in phase: All subjects qualifying for the study will entered into a placebo run-in phase will receive one soft gelatine placebo capsule (swallowed whole and not chewed) and one oral disintegrating placebo tablet OD (dissolved on the tongue then swallowed not chewed), following the first meal each day for four weeks. Randomized treatment phase: Subjects will be instructed to take 1 placebo dutasteride 0.5mg capsule (swallowed whole and not chewed) and one tamsulosin 0.2mg tablet OD (dissolved on the tongue then swallowed not chewed) following the first meal each day for 104 weeks. |
| Dutasteride | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 Fasted condition | EXPERIMENTAL | Each subject will receive both treatments A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fasting conditions. |
| Cohort 2 Fed condition | EXPERIMENTAL | Each subject will receive both treatment A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fed (high fat breakfast) conditions. |
| Dutasteride with/ without Tamsulosin | EXPERIMENTAL | All subjects will be assigned to the same treatment group |
| dutasteride/tamsulosin | EXPERIMENTAL | 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. |
| tamsulosin | ACTIVE_COMPARATOR | Tamsulosin (Omnic®) is an alpha-1A-adrenocepter blocking agent approved for the treatment of signs and symptoms of benign prostatic hyperplasia |
| Fixed dose combination product | EXPERIMENTAL | Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg |
| Harnal-D Tablets | EXPERIMENTAL | Commercial formulation of Harna--D Tablets comprising 0.2mg Tamsulosin Hydrochloride |
| Dutasteride (0.5mg) | EXPERIMENTAL | Commercial formulation of dutasteride |
| Harnal-D Tablets and Harnal capsules | EXPERIMENTAL | Commercial formulations of Harnal-D Tablets and Harnal Capsules both comprising 0.2mg tamsulosin HCl |
| 0.5 mg novel dose form (test) | EXPERIMENTAL | 0.5 mg novel dose form (test) |
| 0.5 mg Soft Gel Capsule | OTHER | 0.5 mg Soft Gel Capsule (reference) |
| Name | Type | Description |
|---|---|---|
| Dutasteride 0.5mg capsules | DRUG | Dutasteride 0.5mg capsules will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules. |
| Dutasteride placebo capsules | DRUG | Dutasteride placebo will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules. |
| Tamsulosin 0.2mg tablets | DRUG | Commercially available tamsulosin 0.2mg tablets will be supplied. |
| Disintegrating placebo tamsulosin tablet | DRUG | Disintegrating placebo tamsulosin tablet will be supplied for the run-in period. |
| Dutasteride | DRUG | once daily |
| Placebo | DRUG | once daily |
| FDC capsule of dutasteride and tamsulosin | DRUG | Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule. |
| Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet | DRUG | Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex. |
| Dutasteride and Tamsulosin | DRUG | 0.5mg dutasteride once a day on Day 1 Period A , and Day 5 Period C,0.2mg Tamsulosin once a day on Day 1 to Day 7 in Period B and Period C |
| dutasteride/tamsulosin | DRUG | 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 |
| tamsulosin | DRUG | 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 |
| Dutasteride (0.5mg, fasted state) | DRUG | Open-label, randomized, single dose, multi-stage, cross-over study |
| Dutasteride (0.5mg, fed state) | DRUG | Commercial formulation of Dutasteride 0.5mg |
| Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state) | DRUG | FDC with 85%, 65% and 0% of the dose as enteric-coated pellets and with X and/or Y% of the dose as enteric-coated pellets (X and Y to be determined from PK results from Stage 1) |
| Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fed state) | DRUG | FDC bioequivalent to Harnal-D tablets |
| Harnal-D Tablets with water (fasted state) | DRUG | Commercial formulation of Harnal-D Tablets |
| Harnal-D Tablets with water (fed state) | DRUG | Commercial formulation of Harnal-D Tablets |
| Harnal-D tablets without water (fasted state) | DRUG | Commercial formulation of Harnal-D Tablets |
| Dutasteride (0.5mg) | DRUG | This study is an open-label, randomized, single dose, four-period cross-over study. |
| FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg) | DRUG | FDC (with 10% enteric coated tamsulosin pellets); (2): FDC (with 15% enteric coated tamsulosin pellets); |
| Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl) | DRUG | a commercial formulation of dutasteride plus tamsulosin HCl (Harnal-D Tablet); (4): a commercial formulation of dutasteride plus tamsulosin HCl(Harnal Capsule). Each dosing session will be separated by a wash-out period of 5 to 10 days |
Inclusion Criteria: * Males, aged \>=50 years * Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) * International Prostate Symptom Score (IPSS) \>=12 points at Screening * Prostate volume \>=30cc (by TRUS) * Total serum Prostate Spec...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | — | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | NA | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | NA | Undisclosed |
| Profound Medical Corp | PROF | 1 | — | Undisclosed |