Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-01-13, after 2022-11-29 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2023-01-13. 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: subjectto determinepriordetermine theheart
Phrases that lowered it: bioequivalencehealthymetformincrossoversingle dose -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Drug's FAERS reports with a death: 8.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 32896 (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 66.9% (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: 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
- 1 (typical: 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
- 33 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 461925 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 32896 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- metformin, metformin sitagliptin, sitagliptin
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 Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany) NCT05132023 · started 2019 · scored riskier than 0% of active trials completed
- Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study NCT03583385 · started 2018 · scored riskier than 1% of active trials completed
- Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet® NCT06103747 · started 2023 · scored riskier than 0% of active trials completed
- A Bioequivalence Study of Glibenclamide From Glibesyn 5 mg Tablets (Medochemie LTD Cyprus) and Daonil 5 mg Tablets (Sanofi-Aventis Cyprus Ltd. ) NCT03855306 · started 2018 · 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
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.