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

NCT05250141 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-03-08

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Levodopa 250mg and Carbidopa 25mg Test Drug tablet

Investigational Medicinal Product

DRUG

Levodopa 250mg and Carbidopa 25mg Referent Product tablet

Sinemet (Savio Industrial S.R.L, Brazil)

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250141 on ClinicalTrials.gov