Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions

NCT04689919 on ClinicalTrials.gov Phase 1 University of Karachi (academic or other) Started 2022-02-19 Completed

Among the lowest-risk 1% of active trials

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 11% of the time (918 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-04-05, after 2022-02-19 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 2022-04-05. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subject haspriorriskheadmonths
Phrases that lowered it: healthytabletsingle dosebioequivalencesubjects
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Primary purpose: other (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 14.0% (lowers risk) · Drug's FDA history
Maximum age: 55 (lowers risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Blinding: none (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Collaborators: 2 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 12 (lowers risk) · Sponsor's track record
Disease area, psychiatry: No (lowers risk) · Disease area
Sponsor's past trials: 12 (lowers risk) · Sponsor's track record

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: principal investigator (typical: sponsor)
Collaborators: 2 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 55 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 12 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 12 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 169524 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9951 (typical: 412.5)
Drug's FAERS reports marked serious: 84.8% (typical: 85.6%)
Drug's FAERS reports with a death: 14.0% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: rivaroxaban

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 Anplag® 90mg (Ticagrelor) Tablet & Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition NCT04941196 · started 2020 · scored riskier than 1% of active trials completed
Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects NCT05841446 · started 2021 · scored riskier than 0% of active trials completed
A Study of LY2216684 and Warfarin in Healthy Subjects NCT01263119 · started 2010 · scored riskier than 2% of active trials completed
Study of Pharmacodynamic Equivalence of Enoxaparin Rovi to Clexane®, in Healthy Volunteers NCT03363477 · started 2015 · scored riskier than 1% of active trials completed
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers NCT06689436 · started 2024 · 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.