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Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions

NCT04386876 on ClinicalTrials.gov Phase 1 World Medicine ILAC SAN. ve TIC. A.S. (industry) Started 2020-04-30 Completed
Among the lowest-risk 1% of active trials
this trial: 2% 0% 36%

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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2020-06-11, after 2020-04-30 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

0% 25% 50% 75% 100% 0123456 yr completed 99% terminated 1%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-06-11. 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

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
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
2 (typical: 0)
Keywords listed
7 (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
0 (typical: 32)
Sponsor's past termination rate
no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years
0 (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
46236 (typical: 2148)
Drug's FAERS reports in the prior 12 months
3116 (typical: 412.5)
Drug's FAERS reports marked serious
91.1% (typical: 85.6%)
Drug's FAERS reports with a death
10.7% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
lopinavir, lopinavir ritonavir, ritonavir

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

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.