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NCT00618111 Clinical Trial

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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00618111
Other study ID # GRAN-T1-PVFD-1
Secondary ID
Status Completed
Phase N/A
First received January 30, 2008
Last updated January 19, 2018
Start date March 2005
Est. completion date April 2005

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Granisetron

Locations
Country Name City State
United States MDS Pharma Services Lincoln Nebraska

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, 4-period, 7 day washout
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