Trials / Unknown
UnknownNCT04513340
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS | CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2020-09-05
- Completion
- 2021-02-13
- First posted
- 2020-08-14
- Last updated
- 2020-09-10
Locations
1 site across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04513340. Inclusion in this directory is not an endorsement.