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NCT04718181 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
NCT04718181: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT04718181 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 131 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04718181, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
Study Summary
The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the current risdiplam oral solution formulation in healthy male and female participants. The effect of food on these two dispersible tablets and the current oral solution will be studied, as well as the effect of omeprazole on the dispersible tablets.
Interventions
- DRUG omeprazole
- DRUG risdiplam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2023-01-28 |
| Phase | Phase 1 |
What the finished NCT04718181 record still lists
NCT04718181 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 2 interventions - of which omeprazole is the first listed.
NCT04718181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04718181 about?
NCT04718181 is a clinical study titled "Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants". The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the current risdiplam oral solution formulation in healthy male and female par...
What is the current status of trial NCT04718181?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2021-02-01. Estimated completion is 2023-01-28.
What interventions are being tested in trial NCT04718181?
The interventions under investigation include: omeprazole (DRUG), risdiplam (DRUG).
Who is sponsoring clinical trial NCT04718181?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04718181's enrollment target sits among peer trials
131 439th of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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