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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618254

Enrollment

Registered

2008-02-19

Start date

2005-03-31

Completion date

2005-04-30

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

Prevention of nausea and vomiting associated with radiation or chemotherapy

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.

Interventions

DRUGGranisetron

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, four period, 7 day washout

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026