Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.

NCT06642987 on ClinicalTrials.gov Phase 1 Hanlim Pharm. Co., Ltd. (industry) Started 2023-10-23 Completed

Among the lowest-risk 1% of active trials

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 (176 trials).

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

How it ended

Completed on 2024-02-23, after 2023-10-23 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 2024-02-23. 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: chronicwomeninvestigationalsurgerychest
Phrases that lowered it: healthybioequivalencecrossoversingle dosetablet
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
Phase: 1 (lowers risk) · Design
Primary purpose: other (lowers risk) · Design
Minimum age: 19 (lowers risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 21.3% (raises risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Drug's FAERS reports marked serious: 97.4% (raises risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 19 (typical: 18)
Maximum age: not given (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: 31 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (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: 3402 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 872 (typical: 412.5)
Drug's FAERS reports marked serious: 97.4% (typical: 85.6%)
Drug's FAERS reports with a death: 21.3% (typical: 15.9%)

Disease area and drugs

Disease areas: digestive
Drugs matched to FDA substances: vonoprazan

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 Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan) NCT05135793 · started 2021 · scored riskier than 0% of active trials completed
Study to Evaluate the Bioequivalence of Crecheck Tablet 2.5 mg (Rosuvastatin Calcium) and Crestor Tablet 5 mg (Rosuvastatin Calcium) in Healthy Adult Subjects NCT06475872 · started 2023 · scored riskier than 0% of active trials completed
Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets NCT07278349 · started 2025 · scored riskier than 0% of active trials completed
A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants NCT06831344 · started 2025 · scored riskier than 0% of active trials completed
Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects NCT06360445 · started 2022 · 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.