Study Details

Study Objective

The purpose of this study is to see if an investigational [new/not available on the market and not yet approved by the U.S Food and Drug Administration (FDA)] capsule is bioequivalent (where the active test study drug is absorbed into the body at the same rate and amount as an already approved drug) to a currently marketed capsule, as well as to monitor the safety of the study participants.

Study Schedule

General Screening

N/A

Medical Screening

Dec 21, 22, 23,28, 29 and 30

Study Visit(s)

Group 1 / Period I
Check-in: Mon, Jan 10,2022
Check-out: Wed, Jan 12,2022
Ambulatory Visit 1: Thu, Jan 13,2022
Ambulatory Visit 2: Fri, Jan 14,2022

Group 1 / Period II
Check-in: Mon, Jan 17,2022
Check-out: Wed, Jan 19,2022
Ambulatory Visit 1: Thu, Jan 20,2022
Ambulatory Visit 2: Fri, Jan 21,2022

Group 2 / Period I
Check-in: Wed, Jan 12,2022
Check-out: Fri, Jan 14,2022
Ambulatory Visit 1: Sat, Jan 15,2022
Ambulatory Visit 2: Sun, Jan 16,2022

Group 2 / Period II
Check-in: Wed, Jan 19,2022
Check-out: Fri, Jan 21,2022
Ambulatory Visit 1: Sat, Jan 22,2022
Ambulatory Visit 2: Sun, Jan 23,2022

Follow-Up Visit(s)

N/A

Other Notes

General good health and non-smoker

Study requires overnight stays