Trials / Completed
CompletedNCT05162053
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers
A Phase 1, Open-label, Randomized, Multiple-dose, Crossover Pharmacokinetic/Pharmacodynamic Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Phenotypes
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vicagrel Capsules | Oral administration for 7 days under fasting |
| DRUG | Clopidogrel Tablets | Oral administration for 7 days under fasting |
Timeline
- Start date
- 2021-12-09
- Primary completion
- 2022-11-03
- Completion
- 2022-11-03
- First posted
- 2021-12-17
- Last updated
- 2023-11-03
Locations
3 sites across 2 countries: United States, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05162053. Inclusion in this directory is not an endorsement.