NCT00946504

CompletedPhase 1

To Demonstrate the Relative Bioequivalency Comparing Geneva'...

Sandoz Source

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Other study identifiers

Sponsor study identifier

9208525-G2

Study Type

interventional

Actual enrollment (reported)

28

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 1992

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 1992

Actual (reported)

Study Completion

October 1992

Actual (reported)

Brief Summary

To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.

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): 28 participants
Study completion date: October 1992
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

Study Start
October 1992
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 1992
Actual (reported)
Study Completion
October 1992
Actual (reported)
First Submitted
July 24, 2009
Actual (reported)
First Posted
July 27, 2009
Actual (reported)

Last Updated: March 28, 2017
Status Verified: July 2009
Last Update Submitted: March 27, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Bioequivalence based on AUC and Cmax
9 days

Study Arms (2)

1

EXPERIMENTAL

Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)

Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)

2

ACTIVE COMPARATOR

Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Interventions

Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)Drug

1

Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)Drug

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexmale

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:

Sponsors & Collaborators

Sandoz
Industrylead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glipizide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsSulfonesSulfur CompoundsOrganic Chemicals

Study Officials

Roger D. Anderson, M.D.
Biodecision, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

28 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

July 24, 2009

First Posted

July 27, 2009

Study Start

October 1992

Date type not reported

This date has not been verified as actual or estimated.

Phase 1

Unknown

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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

October 1992

Actual (reported)

Study Completion

October 1992

Actual (reported)

Last Updated

March 28, 2017

Record last verified: 2009-07

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.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00946504
Data provider: ClinicalTrials.gov
Source updated: 2017-03-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:37 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