NCT00865033

Brief Summary

The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

Same day

First QC Date

March 15, 2009

Last Update Submit

March 27, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

    9 days

Study Arms (2)

1

EXPERIMENTAL

Metformin HCL Tablets, 1000 mg

Drug: Metformin HCL Tablets, 1000 mg Sandoz

2

ACTIVE COMPARATOR

Glucophage 1000 mg Tablets

Drug: Glucophage 1000 mg

Interventions

Metformin HCL Tablets, 1000 mg SandozDRUG
1
Glucophage 1000 mgDRUG
2

Eligibility Criteria

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

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Soran Hong, M.D.

    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

Study Record Dates

First Submitted

March 15, 2009

First Posted

March 19, 2009

Study Start

November 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

March 29, 2017

Record last verified: 2009-03