A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions

Not Applicable

Completed

• Conditions: Nausea; Vomiting

• Registration Number: NCT00618111
• Lead Sponsor: Roxane Laboratories

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 single 1 mg dose, under fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, 4-period, 7 day washout

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Lincoln, Nebraska, United States