drugset / Trial / NCT02667535
PK, PD and Safety Comparative Trial of Isosorbide Mononitrate Gel in Healthy Participants and With Anal Fissure
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Isosorbide Mononitrate gel for usage in participants with anal fissure and healthy volunteers. Three doses will be used in patients with anal fissure (0.5%, 1.0% or 2.0%) and healthy volunteers will receive 2.0% dose. All treatment will last 7 days.
Timeline
- Start
- 2017-07
- Primary completion
- 2017-10
- Completion
- 2017-11
Outcome
Outcome not reported
Stopped: “Study has been cancelled and it has not been initiated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isosorbide Mononitrate | Other / unclassified | 0.5 % | Other |
| Subject | Isosorbide Mononitrate | Other / unclassified | 1 % | Other |
| Subject | Isosorbide Mononitrate | Other / unclassified | 2 % | Other |
Indications
No indication recorded.