NCT00865033

CompletedPhase 1

A Relative Bioavailability Study of Metformin HCL Tablets, 1...

Sandoz Source

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Other study identifiers

Sponsor study identifier

B053709

Study Type

interventional

Actual enrollment (reported)

32

Locations

0 countries

Sites

N/A

Timeline

Study Start

November 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2005

Actual (reported)

Study Completion

November 2005

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: November 2005
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)
Study Completion
November 2005
Actual (reported)
First Submitted
March 15, 2009
Actual (reported)
First Posted
March 19, 2009
Actual (reported)

Last Updated: March 29, 2017
Status Verified: March 2009
Last Update Submitted: 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:

Sponsors & Collaborators

Sandoz
Industrylead

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

Enrollment

32 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Phase 1

Completed

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Phase 1Completed

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Phase 1Completed

NCT00946504

To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets

Phase 1Completed

NCT04065581

Bioequivalence Study for Acarbose/Metformin FDC

Phase 1Completed

NCT00975052

A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

Phase 1Completed

NCT02012166

A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)

Phase 1Completed

Positive test results for HIV or hepatitis B or C.

Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Primary Completion

November 2005

Actual (reported)

Study Completion

November 2005

Actual (reported)

Last Updated

March 29, 2017

Record last verified: 2009-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00865033
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:29 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record