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Comparison of Aramchol Concentrations With Once or Twice Daily Dosing

NCT03774173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-08-09

No results posted yet for this study

Summary

The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily and 600 mg once daily.

Conditions

  • Healthy

Interventions

DRUG

Aramchol

One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • Analyst Research Laboratories

    collaborator OTHER

  • Diamond Pharma Services Regulatory Affairs Consultancy

    collaborator OTHER

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Adeep Puri, M.D. · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-08
Primary Completion
2019-02-03
Completion
2019-03-05

Countries

  • United Kingdom

Study Locations

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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 NCT03774173 on ClinicalTrials.gov