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Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions

NCT02956525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-02-09

No results posted yet for this study

Summary

Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Dexibuprofen

Dexibuprofen 200 mg

Sponsors & Collaborators

  • Apsen Farmaceutica S.A.

    lead INDUSTRY

Principal Investigators

  • Dra. Regina Mayumi Doi, MD · Azidus

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-07-01
Completion
2018-07-01

Countries

  • Brazil

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 NCT02956525 on ClinicalTrials.gov