Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
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 (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.
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. 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: clinical relevancemultiplechronicdose studyer
Phrases that lowered it: healthytabletbioequivalencebmimg -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 4.5% (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 195 (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past trials: 89 (lowers risk) · Sponsor's track record
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Maximum age: 40 (lowers risk) · Who can join
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
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 40 (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
- 89 (typical: 32)
- Sponsor's past termination rate
- 4.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 195 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers NCT01214109 · started 2010 · scored riskier than 1% of active trials completed
- Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects NCT07519278 · started 2017 · scored riskier than 0% of active trials completed
- Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023 NCT05354349 · started 2022 · scored riskier than 6% of active trials completed
- Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects NCT03399734 · started 2017 · scored riskier than 0% of active trials completed
- A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628 NCT06840925 · started 2025 · 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.