PK Comparisons of Bepotastine Besilate 10 mg and Bepotastine Salicylate 9.64 mg
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 9% of the time (74 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 2011-08-31, after 2011-04-30 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 2011-08-31. 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: acutenewlyevidencecharacteristicshematologic
Phrases that lowered it: healthysubjectskgpharmacokineticformulation -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Primary purpose: not given (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 55.6% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 20 (lowers risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Maximum age: 45 (lowers risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Responsible party: principal investigator (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
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 279 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 130 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 55.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology, dermatology
- Drugs matched to FDA substances
- bepotastine, bepotastine besilate, salicylate
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 Dosing Clinical Trial of HL151 NCT02682745 · started 2016 · scored riskier than 0% of active trials completed
- Repeated Dosing Clinical Trial of HL151 NCT02686294 · started 2016 · scored riskier than 0% of active trials completed
- A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers NCT01925313 · started 2012 · scored riskier than 0% of active trials completed
- Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers NCT02332044 · started 2014 · scored riskier than 0% of active trials completed
- Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects NCT03200496 · started 2017 · scored riskier than 0% 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.