Table 1.
Screen | Phase A | Phase B | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Site | R | R | H | R | H | R | H | R | H | R | R | R | R |
Product | 1 | 1 | 2 | 2 | 3 | 3 | 4 | 4 | 1 | 2 | 3 | 4 | |
sRAI | • | • | • | • | |||||||||
Assessments | |||||||||||||
Safety | • | • | • | • | • | • | • | • | • | • | • | • | • |
Acceptability | • | • | • | • | • | • | • | • | |||||
Pharmacokinetics | • | • | • | • | • | • | • | • | |||||
Pharmacodynamics | • | • | • | • |
Site: R, research clinic; H, home.
Product type: randomized sequence of single dose of four different study products—aqueous gel, aqueous fluid, lipid gel, lipid fluid.
sRAI, simulated receptive anal intercourse.