drugset / Trial / NCT05064800
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
Non-randomizedCrossoverOpen-labelBasic science
Summary
This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate
Timeline
- Start
- 2021-09-21
- Primary completion
- 2021-12-06
- Completion
- 2021-12-06
Publications
- Cox DS, Rehman M, Khan T, Ginman K, Salageanu J, LaBadie RR, Wan K, Damle B. Effects of nirmatrelvir/ritonavir on midazolam and dabigatran pharmacokinetics in healthy participants. Br J Clin Pharmacol. 2023 Nov;89(11):3352-3363. doi: 10.1111/bcp.15835. Epub 2023 Jul 12.
- Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dabigatran | Unknown | 75 mg | Oral |
| Subject | Nirmatrelvir | Small molecule | 300 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
Indications
No indication recorded.