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

NCT ID: NCT05128175

Last Updated: 2021-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2022-03-25

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.

Conditions

Parkinson Disease

Keywords

WD-1603; Carbidopa-Levodopa Extended-Release Tablets

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

25 mg /100 mg treatment A group

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

Group Type: EXPERIMENTAL

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Intervention Type: DRUG

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.

25 mg /150 mg treatment B group

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

Group Type: EXPERIMENTAL

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Intervention Type: DRUG

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.

25 mg /150 mg treatment C group

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

Group Type: EXPERIMENTAL

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Intervention Type: DRUG

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.

25 mg /150 mg treatment D group

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

Group Type: EXPERIMENTAL

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Intervention Type: DRUG

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.

25 mg /100 mg placebo group

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

Group Type: PLACEBO_COMPARATOR

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

Intervention Type: DRUG

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.

Interventions

WD-1603 Carbidopa-Levodopa Extended-Release Tablets

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.

Intervention Type: DRUG

Other Intervention Names

WD-1603

Eligibility Criteria

Inclusion Criteria

1. Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive).

2. 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.

3. 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.

4. 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

1. Known hypersensitivity or idiosyncratic reaction to Carbidopa or Levodopa or any of the excipients or any related drug.

2. 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.

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai WD Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akash Patel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutic Research Ltd.

Locations

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, India

Site Status: RECRUITING

Countries

India

Central Contacts

Akash Patel, M.D.

Role: CONTACT

Phone: + 91-79-40202020

Email: business@lambda-cro.com

Facility Contacts

Akash Patel, M.D.

Role: primary

Other Identifiers

WD-1603-1005

Identifier Type: -

Identifier Source: org_study_id