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

NCT ID: NCT04513340

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2021-02-13

Brief Summary

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Treatment A will be given under fed conditions by intra-oral single dose administration

Group Type: EXPERIMENTAL

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

Intervention Type: DRUG

CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG

Treatment B

Treatment B will be given intra-orally and orally under fed conditions by single dose administration

Group Type: EXPERIMENTAL

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

Intervention Type: DRUG

CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG

Treatment C

Treatment C will be given orally under fed conditions by single dose administration

Group Type: EXPERIMENTAL

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

Intervention Type: DRUG

CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG

Treatment D

Treatment D will be given orally under fasting conditions by single dose administration

Group Type: EXPERIMENTAL

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

Intervention Type: DRUG

CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG

Interventions

WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS

CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong WD Pharmaceutical Co., Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lambda Therapeutic Research Ltd.

Ahmedabad, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Xiaoxiong Wei, Doctor

Role: CONTACT

xiaoxiong.wei@wdpharma.com

+86-21-6859-9718

Facility Contacts

Alpesh Jaswantlal Parmar, Doctor

Role: primary

alpeshjparmar@lambda-cro.com

+ 91-79-40202020

Other Identifiers

WD-1603-1002

Identifier Type: -

Identifier Source: org_study_id