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

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 asweight in kg / height in m2.

3. Not having any significant disease or clinically significant abnormal findings duringscreening, medical history, clinical examination, laboratory evaluations, 12- lead ECGand X-ray chest (P/A view) recordings.

4. Able to understand and comply with the study procedures, in the opinion of theprincipal 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 childbearing potential is willing to use a suitable and effective double barrier contraceptivemethod 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 ofthe excipients or any related drug.

2. History or presence of any disease or condition which might compromise thehaemopoietic, 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 includingherbal remedies) at any time within 14 days before dosing in Period I. In any suchcase 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 orNSAIDs induced urticaria.

5. Use of any recreational drugs or history of drug addiction or testing positive inpre-study drug scans.

6. A recent history of harmful use of alcohol (less than 2 years), i.e. alcoholconsumption of more than 14 standard drinks per week for men and more than 7 standarddrinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml ofwine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) orconsumption of alcohol or alcoholic products within 48 hours prior to dosing in PeriodI.

7. Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain fromsmoking 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 firstdose of study medication.

12. Receipt of an investigational medicinal product or participation in a drug researchstudy 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 noblood loss except safety lab testing, subject can be included considering 10half-lives duration of investigational medicinal product received.

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

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 toreceiving the study medicine in period I. In any such case subject selection will beat the discretion of the Principal Investigator.

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

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

18. Nursing mothers (females).