Status:
COMPLETED
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
19-45 years
Phase:
NA
Brief Summary
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a singl...
Eligibility Criteria
Inclusion
- No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to granisetron or any other comparable or similar drug.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00618254
Start Date
March 1 2005
End Date
April 1 2005
Last Update
January 23 2018
Active Locations (1)
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1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502