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

November 10, 2021 updated by: Shanghai WD Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 382481
        • Recruiting
        • Lambda Therapeutic Research Ltd.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 25 mg /100 mg treatment A group
Treatment A: carbidopa/levodopa (25 mg /100 mg)
Drug: 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.
Other Names:
  • WD-1603
EXPERIMENTAL: 25 mg /150 mg treatment B group
Treatment B: carbidopa/levodopa (25 mg/150mg)
Drug: 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.
Other Names:
  • WD-1603
EXPERIMENTAL: 25 mg /150 mg treatment C group
Treatment C: carbidopa/levodopa (25 mg /150 mg)
Drug: 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.
Other Names:
  • WD-1603
EXPERIMENTAL: 25 mg /150 mg treatment D group
Treatment D: carbidopa/levodopa (25 mg /150 mg)
Drug: 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.
Other Names:
  • WD-1603
PLACEBO_COMPARATOR: 25 mg /100 mg placebo group
Treatment E(Reference): Carbidopa and Levodopa tablets (a generic version of Sinemet® IR) 25 mg/100 mg
Drug: 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.
Other Names:
  • WD-1603

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 24 hours-from morning of Day 1 to 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.
24 hours-from morning of Day 1 to morning of Day 2
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.
Time Frame: 24 hours-from morning of Day 1 to morning of Day 2
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.
24 hours-from morning of Day 1 to morning of Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai WD Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Akash Patel, M.D., Lambda Therapeutic Research Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 29, 2021

Primary Completion (ANTICIPATED)

January 25, 2022

Study Completion (ANTICIPATED)

March 25, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (ACTUAL)

November 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WD-1603-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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