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

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00618111
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 31.4

Study Details

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 fed conditions.

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting	Drug: Granisetron	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [Baseline, 4-period, 7 day washout]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MDS Pharma Services	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Roxane Laboratories

Investigators

• Principal Investigator: James Kissling, M.D., MDS Pharma Services

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00618111
• Other Study ID Numbers: GRAN-T1-PVFD-1
• First Posted: Feb 18, 2008
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by , ,: Prevention of nausea and vomiting associated with radiation or chemotherapy
• Additional relevant MeSH terms: Nausea; Vomiting; Granisetron

Study Results

No Results Posted as of Jan 23, 2018