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

NCT05250141 | Completed Phase 1

• 1 other identifier: HP8813-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Total Levodopa and Carbidopa: area under the plasma concentration-time curve from 0 to time t (AUC0-t)

  23 samples up to 10 hours will be taken after the administration in each period

• Total Levodopa and Carbidopa: area under the plasma concentration-time curve from 0 to time t (AUC0-∞)

  23 samples up to 10 hours will be taken after the administration in each period

• Total Levodopa and Carbidopa: Maximum plasma concentration (Cmax)

  23 samples up to 10 hours will be taken after the administration in each period

• Total Levodopa and Carbidopa: Time to achieve maximum plasma concentration (tmax)

  23 samples up to 10 hours will be taken after the administration in each period

Study Arms (2)

Levodopa and Carbidopa Test Product

EXPERIMENTAL

Participants will receive one tablet of the test formulation containing Levodopa and Carbidopa 250 mg/ 25 mg. The tablet will be taken with water and in a fasting condition.

Drug: Levodopa 250mg and Carbidopa 25mg Test Drug tablet

Levodopa and Carbidopa Referent Product

EXPERIMENTAL

Participants will receive one tablet of the marketed reference containing Levodopa and Carbidopa 250 mg/ 25 mg. The tablet will be taken with water and in a fasting condition.

Drug: Levodopa 250mg and Carbidopa 25mg Referent Product tablet

Interventions

Levodopa 250mg and Carbidopa 25mg Test Drug tablet DRUG

Investigational Medicinal Product

Levodopa and Carbidopa Test Product

Levodopa 250mg and Carbidopa 25mg Referent Product tablet DRUG

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

Levodopa and Carbidopa Referent Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
• Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• Normal or clinically insignificant ECG.
• Negative urine test for drugs of abuse for both males and females and negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
• Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for at least 1 month after the last drug administration.
• Volunteers who can give written informed consent and communicate effectively.

You may not qualify if:

• History of any major surgical procedure in the past 03 months.
• History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• History of chronic alcoholism/ chronic smoking/ drug of abuse.
• Volunteers with known hypersensitivity to Levodopa and Carbidopa or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Levodopa and Carbidopa or any other medication judged to be clinically significant by the investigator.
• History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
• Volunteers who are dysphagic

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Azidus Laboratories Ltd.

Chennai, Tamil Nadu, 600048, India

Location

MeSH Terms

Interventions

Levodopa; Carbidopa; Drug Evaluation

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: February 14, 2022
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)