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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04513340
• Date of registration: 12/08/2020
• Prospective Registration: Yes
• Primary sponsor: Hong Kong WD Pharmaceutical Co., Limited
• Public title: WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects
• Scientific title: 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
• Date of first enrolment: August 13, 2020
• Target sample size: 8
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04513340
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Xiaoxiong Wei, Doctor

• Name: Alpesh Jaswantlal Parmar, Doctor

Key inclusion & exclusion 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.

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.

11. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first
dose of study medication.

12. Receipt of an investigational medicinal product or participation in a drug research
study within a period of 90 days prior to the first dose of study medication**.

** If investigational medicinal product is received within 90 days where there is no
blood loss except safety lab testing, subject can be included considering 10
half-lives duration of investigational medicinal product received.

13. A positive hepatitis screen including hepatitis B surface antigen and/or HCV
antibodies.

14. A positive test result for HIV (1 &/or 2) antibody.

15. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to
receiving the study medicine in period I. In any such case subject selection will be
at the discretion of the Principal Investigator.

16. Consumption of grapefruit or grapefruit products within 72 hours prior to dosing in
period-I.

17. Difficulty in swallowing oral solid dosage form like tablets or capsules.

18. Nursing mothers (females).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

Primary Outcome(s)

AUC0-8 [Time Frame: Day 1 and Day 2]

Cmax [Time Frame: Day 1 and Day 2]

AUC0-t [Time Frame: Day 1 and Day 2]

Secondary Outcome(s)

t1/2 [Time Frame: Day 1 and Day 2]

Tmax [Time Frame: Day 1 and Day 2]

Secondary ID(s)

WD-1603-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors