PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2017

Primary Completion Date

October 31, 2017

Study Completion Date

November 30, 2017

Conditions
Anal Fissure
Interventions
DRUG

Isosorbide Mononitrate

"Healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days.~Participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days."

Sponsors
All Listed Sponsors
lead

Biolab Sanus Farmaceutica

INDUSTRY