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Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring WD-1603, Carbidopa-Levodopa Extended-Release Tablets

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).
Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg.
Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG, and X-ray chest (P/A view) recordings.
In the case of female subjects:

a. Surgically sterilized at least 6 months prior to study participation or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration.

And b. Serum Pregnancy test must be negative.

Exclusion Criteria:

Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.
History or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
Ingestion of a medicine (prescribed & over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before first dosing in Period I. In any such case, subject selection will be at the discretion of the Principal Investigator.

Sites / Locations

Lambda Therapeutic Research Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

25 mg /100 mg treatment A group

25 mg /150 mg treatment B group

25 mg /150 mg treatment C group

25 mg /150 mg treatment D group

25 mg /100 mg placebo group

Arm Description

Treatment A: carbidopa/levodopa (25 mg /100 mg)

Treatment B: carbidopa/levodopa (25 mg/150mg)

Treatment C: carbidopa/levodopa (25 mg /150 mg)

Treatment D: carbidopa/levodopa (25 mg /150 mg)

Treatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg

Outcomes

Primary Outcome Measures

Cmax of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg from the morning of day 1 to the morning of day 2.

To evaluate Cmax (Maximum Plasma Concentration) of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects.

The duration (hours) for the levodopa concentrations ≥ 50% of Cmax between WD-1603 extended-release formulations and carbidopa and levodopa tablets following three times a day orally administration in healthy subjects.

To compare the duration (hours) for the levodopa concentrations ≥ 50% of Cmax, where maximum measured plasma concentration after 1st dose or 2nd or 3rd dose for each dose interval.

Secondary Outcome Measures

Full Information

NCT ID

NCT05128175

First Posted

October 27, 2021

Last Updated

November 10, 2021

Sponsor

Shanghai WD Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05128175

Brief Title

Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions

Official Title

An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 29, 2021 (Actual)

Primary Completion Date

January 25, 2022 (Anticipated)

Study Completion Date

March 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai WD Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

It is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. The primary objective of the study is to compare the pharmacokinetic profiles between WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.

Detailed Description

Study WD-1603-1005 is to compare the fluctuation index between WD-1603 extended-release formulations and Carbidopa and Levodopa Tablets following three times a day oral administration and the food effect on the initial absorption of levodopa in the morning in healthy subjects. At least 15 subjects will be enrolled at the beginning of the study and the order of receiving the Treatment A, B, C, D & E for each subject during all the periods of the the study will be determined according to a randomization schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

WD-1603, Carbidopa-Levodopa Extended-Release Tablets

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

25 mg /100 mg treatment A group

Arm Type

Experimental

Arm Description

Treatment A: carbidopa/levodopa (25 mg /100 mg)

Arm Title

25 mg /150 mg treatment B group

Arm Type

Experimental

Arm Description

Treatment B: carbidopa/levodopa (25 mg/150mg)

Arm Title

25 mg /150 mg treatment C group

Arm Type

Experimental

Arm Description

Treatment C: carbidopa/levodopa (25 mg /150 mg)

Arm Title

25 mg /150 mg treatment D group

Arm Type

Experimental

Arm Description

Treatment D: carbidopa/levodopa (25 mg /150 mg)

Arm Title

25 mg /100 mg placebo group

Arm Type

Placebo Comparator

Arm Description

Treatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg

Intervention Type

Drug

Intervention Name(s)

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Other Intervention Name(s)

WD-1603

Intervention Description

For fasting conditions in the morning, a single oral dose will be administered to each subject under fasting conditions before 5 minutes of serving a standardized vegetarian breakfast as per the randomization schedule; for fasting conditions in the afternoon and evening, a single oral dose will be administered to each subject under fasting condition before 5 minutes of serving standardized vegetarian lunch and dinner as per randomization schedule. For fed condition, single oral dose will be administered to each subject after 30 minutes of serving standardized vegetarian breakfast, lunch and dinner as per randomization schedule. Dosing interval between two subsequent dosing should be 5 hours in each period. There will be one tablet for A, B, C, D and E.

Primary Outcome Measure Information:

Title

Cmax of the pharmacokinetics of WD-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg from the morning of day 1 to the morning of day 2.

Description

Time Frame

24 hours-from morning of Day 1 to morning of Day 2

Title

Description

To compare the duration (hours) for the levodopa concentrations ≥ 50% of Cmax, where maximum measured plasma concentration after 1st dose or 2nd or 3rd dose for each dose interval.

Time Frame

24 hours-from morning of Day 1 to morning of Day 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive). Having a Body Mass Index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg. Not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG, and X-ray chest (P/A view) recordings. In the case of female subjects: a. Surgically sterilized at least 6 months prior to study participation or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration. And b. Serum Pregnancy test must be negative. Exclusion Criteria: Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug. History or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system. Ingestion of a medicine (prescribed & over the counter (OTC) medication including herbal remedies and MAO inhibitors) at any time within 30 days before first dosing in Period I. In any such case, subject selection will be at the discretion of the Principal Investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Akash Patel, M.D.

Phone

+ 91-79-40202020

business@lambda-cro.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akash Patel, M.D.

Organizational Affiliation

Lambda Therapeutic Research Ltd.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lambda Therapeutic Research Ltd.

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

382481

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Akash Patel, M.D.

Phone

+91-7940202020

business@lambda-cro.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions

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