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

NCT03291080 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-19

Study results available
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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.

Conditions

Interventions

DRUG

Liquid 13-Cis Retinoic Acid

Liquid 13-Cis Retinoic Acid

DRUG

Extracted capsules 13-CRA

Extracted capsules 13-CRA

Sponsors & Collaborators

  • Nova Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Hussain Mulla, PhD · Nova Laboratories Limited

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03291080 on ClinicalTrials.gov