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

Roxane Laboratories

Status: Completed

Conditions: Vomiting; Nausea

Treatments: Drug: Granisetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618254

GRAN-T1-PVFS-1

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts 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.