Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The goal of this randomised four-period cross-over Phase I study is to assess
bioavailability, bioequivalence and tolerability of IHL-42X compared to the reference drugs
in healthy volunteers.
Volunteers will be enrolled and randomised to one of four treatment groups. Each group is to
receive all four treatments in a twenty eight day cross-over study, with each treatment
period running for seven days.
The four treatment groups are described below; A = dronabinol 5 mg, fasted; B = acetazolamide
250 mg, fasted; C = IHL-42X (5 mg dronabinol, 250 mg acetazolamide), fasted; D = IHL-42X (5
mg dronabinol, 250 mg acetazolamide), fed. Each treatment group will enrol at least 29
participants each, for a total of at least 116 participants.
Bioavailability and bioequivalence will assess and compare all four of the seven day
treatments.