NCT01591889

Brief Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

May 1, 2012

Last Update Submit

January 19, 2018

Conditions

Trichomoniasis

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    8 days

Study Arms (2)

tindamax

ACTIVE COMPARATOR

500 mg tablet

Drug: Tinidazole

tinidazole

ACTIVE COMPARATOR

500 mg tablet

Drug: Tinidazole

Interventions

TinidazoleDRUG

500 mg tablet

Also known as: Tindamax®
tindamax

Eligibility Criteria

Age18 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 tinidazole or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Trichomonas Infections

Interventions

Tinidazole

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soran Hong, MD

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

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

May 1, 2012

First Posted

May 4, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)