NCT00882882

Brief Summary

To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

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

June 1, 2001

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

March 29, 2017

Status Verified

April 1, 2009

Enrollment Period

Same day

First QC Date

April 16, 2009

Last Update Submit

March 27, 2017

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    23 days

Study Arms (4)

1

EXPERIMENTAL

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

2

EXPERIMENTAL

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

3

ACTIVE COMPARATOR

GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

4

ACTIVE COMPARATOR

GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

Interventions

Metformin HCL 500 mg Extended-Release Tablets, Geneva PTCDRUG
1
GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers SquibbDRUG
3

Eligibility Criteria

Age19 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

  • So Ran Hong, M.D.

    Novum Independent Institutional Review Board

    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

April 16, 2009

First Posted

April 17, 2009

Study Start

June 1, 2001

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

March 29, 2017

Record last verified: 2009-04