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Clinical Trials/IRCT20190706044111N10
IRCT20190706044111N10Not yet recruiting未知

A randomized, open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Dexamethasone 4mg tablet of Abureihan Pharm Co., IRAN in comparison of Dexamethasone 4mg tablet of GALEN in 24 healthy adult subjects under fasting condition

Aburaihan Pharm Co.0 sites24 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
未知
Status
Not yet recruiting
Sponsor
Enrollment
24

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 years to 50 years (—)
Sex
All

Inclusion Criteria

  • Aged between 20 - 50 years
  • Body weight between 50 – 100 kg
  • Having good health on the basis of medical history and physical & clinical examination
  • Understand the procedures and give written informed consent.

Exclusion Criteria

  • Subject showed clinically relevant deviations from normal in physical examination.
  • Subject had undergone surgery of the gastro-intestinal tract
  • Subject had donated a unit of blood or participated in another clinical trial, within the last 8 weeks before the first treatment.
  • Subject had a history of drug or alcohol abuse.
  • Subject who smokes more than 10 cigarettes per day.
  • Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Investigators

Sponsor
Aburaihan Pharm Co.

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