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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Granisetron
Sponsored by
Roxane Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Prevention of nausea and vomiting associated with radiation or chemotherapy

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No clinically significant abnormal finding 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 drug.

Sites / Locations

  • MDS Pharma Services

Outcomes

Primary Outcome Measures

Bioequivalence

Secondary Outcome Measures

Full Information

First Posted
January 30, 2008
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00618254
Brief Title
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Official Title
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roxane Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 fasting conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Prevention of nausea and vomiting associated with radiation or chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Granisetron
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, four period, 7 day washout

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No clinically significant abnormal finding 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 drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kissling, M.D.
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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