NCT05128175

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for phase_1 parkinson-disease

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

November 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

October 27, 2021

Last Update Submit

November 10, 2021

Conditions

Parkinson Disease

Keywords

WD-1603Carbidopa-Levodopa Extended-Release Tablets

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

Study Arms (5)

25 mg /100 mg treatment A group

EXPERIMENTAL

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

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25 mg /150 mg treatment B group

EXPERIMENTAL

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

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25 mg /150 mg treatment C group

EXPERIMENTAL

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

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25 mg /150 mg treatment D group

EXPERIMENTAL

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

Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets

25 mg /100 mg placebo group

PLACEBO COMPARATOR

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

Interventions

WD-1603 Carbidopa-Levodopa Extended-Release TabletsDRUG

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.

Also known as: WD-1603
25 mg /100 mg placebo group25 mg /100 mg treatment A group25 mg /150 mg treatment B group25 mg /150 mg treatment C group25 mg /150 mg treatment D group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Akash Patel, M.D.

    Lambda Therapeutic Research Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Akash Patel, M.D.

CONTACT

+ 91-79-40202020business@lambda-cro.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 19, 2021

Study Start

October 29, 2021

Primary Completion

January 25, 2022

Study Completion

March 25, 2022

Last Updated

November 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)