Trials / Completed
CompletedNCT05491733
A Bioequivalence Study of APX001 High-load and Low-load Tablets
A 3-Treatment, 3-Period, 6-Sequence Randomized Crossover Single-Dose Study Evaluating the Bioequivalence of High-Load and Low-Load Oral Tablet Formulations of Apx001 and the Effect of Food on the Absorption of Apx001 From the High-Load Tablet In Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APX001 | Low-load oral tablet |
| DRUG | APX001A | High-load oral tablet |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2021-05-13
- Completion
- 2021-06-23
- First posted
- 2022-08-08
- Last updated
- 2024-07-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05491733. Inclusion in this directory is not an endorsement.