Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (233 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-12-29, after 2014-02-19 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-12-29. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjects withevidencecoronaryprostatesubjects must
Phrases that lowered it: healthymgbioequivalencesingle dosealcohol -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 323 (raises risk) · Sponsor's track record
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Maximum age: 50 (lowers risk) · Who can join
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Sponsor's past trials: 1908 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 11.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 77.5% (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 5 (lowers risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1908 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 323 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 10608 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2364 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- dutasteride, tamsulosin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State NCT02058576 · started 2014 · scored riskier than 0% of active trials completed
- 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 NCT02184585 · started 2014 · scored riskier than 0% of active trials completed
- 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 NCT02509104 · started 2015 · scored riskier than 1% of active trials completed
- A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State. NCT00609596 · started 2008 · scored riskier than 1% of active trials completed
- 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 NCT01957189 · started 2013 · scored riskier than 2% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.