Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Model scores of the 29,894 trials active now.
Model score 1% 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 (4,470 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 2012-09-10, after 2012-07-31 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 2012-09-10. 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 withdiseasesubject30 daysacute
Phrases that lowered it: bioequivalencehealthyalcoholmgkg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 104 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 24.7% (raises risk) · Drug's FDA history
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Sponsor's past trials: 446 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 50 (lowers risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, psychiatry: No (lowers risk) · Disease area
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
- 3 (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
- 446 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 104 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 13064 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2497 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fluconazole
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
- Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions NCT04038008 · started 2019 · scored riskier than 0% of active trials completed
- Diflucan Bioequivalence Study For Transferring The Manufacture NCT03821480 · started 2019 · scored riskier than 2% of active trials completed
- Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France NCT03621072 · started 2019 · scored riskier than 3% of active trials completed
- Study of Potential for Interaction of Fluconazole With F901318 NCT02730442 · started 2016 · scored riskier than 2% of active trials completed
- Effect of Fluconazole on PK of Fluzoparib in Healthy Male Subjects NCT04193319 · started 2019 · 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.