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WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE1

WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects

AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS

NCT04513340•Hong Kong WD Pharmaceutical Co., Limited

View on ClinicalTrials.gov

Summary

The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
•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. Able to understand and comply with the study procedures, in the opinion of the principal investigator.
•5. Able to give voluntary written informed consent for participation in the trial.
•6. In case of female subjects:
•a. Surgically sterilized at least 6 months prior to study participation or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
•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 haemopoietic, 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) at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
•4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
•5. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
•6. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period I.
•7. Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
•8. The presence of clinically significant abnormal laboratory values during screening.
•9. History or presence of psychiatric disorders.
•10. A history of difficulty in donating blood.
+9 more criteria

Locations (1)

Lambda Therapeutic Research Ltd.

Ahmedabad, India

Key Dates

Start Date

August 13, 2020

Primary Completion Date

September 5, 2020

Completion Date

February 13, 2021

Last Updated

September 10, 2020

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

DRUG

Contacts

Xiaoxiong Wei, Doctor

CONTACT

+86-21-6859-9718 xiaoxiong.wei@wdpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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