drugset / Trial / NCT05250141

Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product

NCT05250141

Phase 1 Completed 44 enrolled Laboratorios Andromaco S.A.
RandomizedCrossoverOpen-labelBasic science

Summary

This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 tablet formulation containing Levodopa 250 mg and Carbidopa 25 mg. The study will be performed at a single site with 44 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

Timeline

Start
2022-02-14
Primary completion
2022-02-17
Completion
2022-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbidopa Unknown 25 mg
Subject Levodopa Small molecule 250 mg

Indications

No indication recorded.