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NCT04768985 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT04768985 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 66 participants.
The verdict
NCT04768985, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.
Interventions
- DRUG Treatment A: Acalabrutinib tablet
- DRUG Treatment B: Acalabrutinib capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2021-05-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04768985
The ClinicalTrials.gov registry entry for NCT04768985 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment A: Acalabrutinib tablet is the first listed.
NCT04768985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04768985 about?
NCT04768985 is a clinical study titled "Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule". This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment ...
What is the current status of trial NCT04768985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2021-02-25. Estimated completion is 2021-05-10.
What interventions are being tested in trial NCT04768985?
The interventions under investigation include: Treatment A: Acalabrutinib tablet (DRUG), Treatment B: Acalabrutinib capsule (DRUG).
Who is sponsoring clinical trial NCT04768985?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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