A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: Granisetron (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
James Kissling, M.D., Principal Investigator, Affiliation: MDS Pharma Services
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 single 1 mg dose, under fed conditions.
Clinical Details
Official title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- 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 product.
Locations and Contacts
MDS Pharma Services, Lincoln, Nebraska 68502, United States
Additional Information
Starting date: March 2005
Ending date: April 2005
Last updated: February 15, 2008
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