NCT00618111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

January 30, 2008

Last Update Submit

January 19, 2018

Conditions

NauseaVomiting

Keywords

Prevention of nausea and vomiting associated with radiation or chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    Baseline, 4-period, 7 day washout

Interventions

GranisetronDRUG

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • James Kissling, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 18, 2008

Study Start

March 1, 2005

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)