In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Tablet given orally
Altasciences Company Inc.
Montreal, Quebec, Canada
Parexel International GmbH
Berlin, Germany
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
h \* nmol/L
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
nmol/L
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
hours
Time frame: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
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