Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Model scores of the 29,894 trials active now.
Model score 3% 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: bmsinabilitysurgerygreaterprior
Phrases that lowered it: healthyfemalesubjectsbioequivalencecrossover -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
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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: 181 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises 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
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 80 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 181 (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
- Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study NCT03583385 · started 2018 · scored riskier than 1% of active trials completed
- GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study NCT04684420 · started 2020 · scored riskier than 0% of active trials completed
- Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers NCT05124717 · started 2019 · scored riskier than 0% of active trials completed
- Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt) NCT03566810 · started 2018 · scored riskier than 0% of active trials completed
- Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions NCT03452306 · 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.