NCT00800475

Brief Summary

The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_1

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

July 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

November 26, 2008

Last Update Submit

August 9, 2013

Conditions

Bioavailability

Keywords

bioavailabilityGemfibrozil

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Study Arms (2)

Test Drug

ACTIVE COMPARATOR
Drug: Gemfibrozil Tablets

Reference Drug

ACTIVE COMPARATOR
Drug: Gemfibrozil Tablets

Interventions

Gemfibrozil TabletsDRUG
Reference DrugTest Drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men or women 18 years of age or older
  • weight within +/- 20% for height and body frame
  • willing to participate and sign a copy of the informed consent form

You may not qualify if:

  • recent history of drug or alcohol addiction or abuse
  • pregnant or lactating women
  • history of allergic response to gemfibrozil
  • use of tobacco products
  • evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
  • receipt of any drugs as part of a research study within 28 days prior to study dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Gemfibrozil

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPentanoic AcidsValeratesPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

December 2, 2008

Study Start

July 1, 2005

Primary Completion

July 1, 2005

Study Completion

September 1, 2005

Last Updated

August 13, 2013

Record last verified: 2013-08