Randomized, Crossover Bioequivalence Study of PL-ASA vs Immediate-release Aspirin in Healthy Volunteers.
Status:
Completed
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence
study to determine PK parameters following treatment with test aspirin product (PL-ASA
capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325
mg.
Healthy volunteers will be asked to sign informed consent prior to conduct any protocol
specified activities at screening. A total of 20 eligible subjects will be randomized, in a
fasted state, to 1 of 2 sequences of study drug administration (each study drug dose contains
325 mg aspirin) at 1:1 ratio:
- PL-ASA capsule, IR-ASA tablet
- IR-ASA tablet, PL-ASA capsule
After completion of the first treatment on Day 1 and following the 24 hours of sample
collection, a minimum of a 7-day washout period will be required before all subjects are
crossed over and receive treatment with the alternative compound; i.e., subject randomized to
receive PL-ASA capsule as a first treatment will receive IR-ASA tablet as the second
treatment, and vice-versa.