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

• Sponsor: Laboratorios Andromaco S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05250141
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Days): 3
• Patients Per Site Per Month: 446.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioequivalence	Drug: Levodopa 250mg and Carbidopa 25mg Test Drug tablet; Drug: Levodopa 250mg and Carbidopa 25mg Referent Product tablet	Phase 1

Detailed Description

The primary objective of the study is to investigate the relative bioavailability of Oseltamivir Phosphate 75 mg of 1 capsule formulations with Oseltamivir Phosphate 75 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

• Test Product: Product manufactured by Laboratorios Silesia S.A.

• Reference Product: Sinemet [Trademark], product of Savio Industrial S.R.L., Brazil. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Levodopa and Carbidopa will be determined. Participants will be confined in the study site for approximately 68 hours during the entire study (for 10 hours pre-dosing and for 10 hours post dosing in period II) during which pharmacokinetic (PK) blood samples will be obtained. 23 blood samples will be taken up to 10 hours after the administration in each period. The washout period between the two study periods will be at least 2 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Levodopa and Carbidopa in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Bioavailability of a Formulation of Oseltamivir Phosphate 75 mg Tablets With Regards to the Reference Product
• Actual Study Start Date: Feb 14, 2022
• Actual Primary Completion Date: Feb 17, 2022
• Actual Study Completion Date: Feb 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levodopa and Carbidopa Test Product 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; Investigational Medicinal Product
Experimental: Levodopa and Carbidopa Referent Product 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; Sinemet (Savio Industrial S.R.L, Brazil)

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. Total Levodopa and Carbidopa: Maximum plasma concentration (Cmax) [23 samples up to 10 hours will be taken after the administration in each period]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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.

2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination.

3. Normal or clinically insignificant biochemical, hematological, urine and serology parameters.

4. Normal or clinically insignificant ECG.

5. 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.

6. 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.

7. Volunteers who can give written informed consent and communicate effectively.

Exclusion Criteria:

1. History of any major surgical procedure in the past 03 months.

2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.

3. History of chronic alcoholism/ chronic smoking/ drug of abuse.

4. Volunteers with known hypersensitivity to Levodopa and Carbidopa or any of the excipients.

5. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing

6. Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1&2) antibodies.

7. 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.

8. History of consumption of grapefruit and/or its products within 10 days prior to the start of study.

9. Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.

10. 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.

11. Volunteers who are dysphagic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azidus Laboratories Ltd.	Chennai	Tamil Nadu	India	600048

Sponsors and Collaborators

• Laboratorios Andromaco S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratorios Andromaco S.A.
• ClinicalTrials.gov Identifier: NCT05250141
• Other Study ID Numbers: HP8813-01
• First Posted: Feb 22, 2022
• Last Update Posted: Mar 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Levodopa; Carbidopa

Study Results

No Results Posted as of Mar 8, 2022