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Clinical Trials/IRCT20200407046981N20
IRCT20200407046981N20Not yet recruiting未知

Comparative bioequivalence study of the Omeprazole 10-mg Sachet manufactured by Kimia Kala Razi Pharmaceutical Company versus Nexium® (AstraZeneca Company)

Kimia Kala Razi Pharmaceutical Company0 sites24 target enrollmentStarted: TBDLast updated:

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 60 years (—)
Sex
Male

Inclusion Criteria

  • The weight limit of each volunteer should be between 60 and 100 kg.
  • All volunteers must be non-smokers.
  • They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
  • Candidates who have consented to the consent form.

Exclusion Criteria

  • Known hypersensitivity or idiosyncratic reaction to omeprazole or any ingredients.
  • Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
  • Regular smoker who smokes more than ten cigarettes daily.
  • Taking any medicine during two weeks before dosing.

Investigators

Sponsor
Kimia Kala Razi Pharmaceutical Company

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