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Generic Formulations of Commonly-used Oral Drugs in Saudi Arabia:Interchangeability & Post-marketing Quality

NCT01344070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-09-01

No results posted yet for this study

Summary

Generic formulations of prescription drugs can, through their relatively lower cost, improve healthcare as long as they maintain their registration-quality and public trust. On the other hand, the market availability of several generic formulations raises a concern regarding their interchangeability, despite being proven to be individually therapeutically interchangeable with their corresponding innovator formulation.

The investigators propose to assess the quality and therapeutic interchangeability of generic formulations in the drug market of Saudi Arabia, using fifteen, commonly-used, oral, solid, immediate-release, and non-combinational drugs.

Conditions

  • Generic Drug Quality
  • Generic Formulation Interchangeability

Interventions

DRUG

one of the 15 drugs listed below

single, oral, immediate-release, non-combinational innovator formulation

DRUG

one of the 15 drugs listed below

single, oral, immediate-release, non-combinational generic formulation a

DRUG

one of the 15 drugs listed below

single, oral, immediate-release, non-combinational generic formulation b

DRUG

one of the 15 drugs listed below

single, oral, immediate-release, non-combinational generic formulation c

Sponsors & Collaborators

  • Saudi National Comprehensive Plan for Science & Technology

    collaborator UNKNOWN

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Muhammad M Hammami, MD, PhD · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Saudi Arabia

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 NCT01344070 on ClinicalTrials.gov