drugset / Trial / NCT03291080

Oral Liquid 13-cis-retinoic Acid (13-CRA)

NCT03291080

Phase 1/2 Completed 20 enrolled Nova Laboratories Limited
RandomizedCrossoverOpen-labelOther

Summary

An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - \< 21 years.

Timeline

Start
2018-04-17
Primary completion
2019-09-12
Completion
2019-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Isotretinoin Other / unclassified 160 mg/m2 Oral
Subject Isotretinoin Other / unclassified 200 mg/m2 Oral

Indications