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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 131 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04718181
The ClinicalTrials.gov registry entry for NCT04718181 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which omeprazole is the first listed.
NCT04718181 reports 0 study locations.
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.
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