Study identifier:D3560C00817
ClinicalTrials.gov identifier:NCT06554821
EudraCT identifier:N/A
CTIS identifier:N/A
An open-label, randomised, parallel-group, fixed-sequence study to assess the effect of oral ticagrelor on the pharmacokinetics of oral rosuvastatin in healthy participants
Healthy Participants
Phase 1
Yes
Rosuvastatin, Ticagrelor
All
28
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Rosuvastatin (Dose 1) + Ticagrelor Participants will receive rosuvastatin (dose 1) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID (twice a day) on Day 6 through Day 10. | Drug: Rosuvastatin Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. Other Name: CRESTOR Drug: Ticagrelor Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10. Other Name: BRILIQUE |
Experimental: Rosuvastatin (Dose 2) + Ticagrelor Participants will receive rosuvastatin (dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID on Day 6 through Day 10. | Drug: Rosuvastatin Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. Other Name: CRESTOR Drug: Ticagrelor Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10. Other Name: BRILIQUE |