Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fed Conditions
1 other identifier
interventional
48
1 country
1
Brief Summary
The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablet under fed conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedJanuary 23, 2018
January 1, 2018
Same day
November 11, 2009
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
bioequivalence determined by statistical comparison Cmax
20 Days
Interventions
Eligibility Criteria
You may qualify if:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
You may not qualify if:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to Perindopril or any comparable or similar product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novum Pharmaceutical Research Services
Houston, Texas, 77042, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
May 1, 2007
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
January 23, 2018
Record last verified: 2018-01