Research Site
Berlin, 14050, Germany
NCT Number: NCT06554821
The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
This study will be conducted at a single Clinical Unit. It includes 2 parallel arms (one for each rosuvastatin dose) and 2 treatment periods.
The study will comprise:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: CRESTOR
Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10.
Other names: BRILIQUE
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on plasma PK (AUCinf) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on plasma PK (AUClast) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on plasma PK (Cmax) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: Approximately 7 weeks
To examine the safety and tolerability of rosuvastatin alone and in combination with ticagrelor.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the PK (t1/2) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the PK (λz) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the PK (tmax) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the urine PK (Ae) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the urine PK (Clrenal) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
To assess the effect of ticagrelor on the urine PK of rosuvastatin in healthy participants.
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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