A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
44actual
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-16 | actual | When the study began enrolling |
| Primary completion | 2026-06-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-05 | actual | The whole study's end, after follow-up |
| First posted | 2026-01-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1
- Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1
- Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2
- Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2
- Drug: Laroprovstat Dose X STP
- Drug: Rosuvastatin Dose 1 STP
- Drug: Rosuvastatin Dose 2 STP
Primary outcomes
what the primary-completion date above is the date OFArea under concentration time curve from time 0 to infinity (AUCinf)
measured At predefined intervals from Day 1 to Day 11
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
measured At predefined intervals from Day 1 to Day 11
Maximum observed drug concentration (Cmax)
measured At predefined intervals from Day 1 to Day 11
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