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CompletedNCT00865033Updated Mar 29, 2017

A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions

A Phase 1 interventional study of Metformin HCL Tablets, 1000 mg Sandoz and Glucophage 1000 mg in Type 2 Diabetes, sponsored by Sandoz. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Sandoz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    1

    Metformin HCL Tablets, 1000 mg

    Drug: Metformin HCL Tablets, 1000 mg Sandoz

  • Active comparator
    2

    Glucophage 1000 mg Tablets

    Drug: Glucophage 1000 mg

Interventions

  • DrugMetformin HCL Tablets, 1000 mg Sandoz
  • DrugGlucophage 1000 mg
06

What researchers measure

Primary outcomes

  1. Bioequivalence according to US FDA guidelines

    Time frame: 9 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00865033
Lead sponsor
Sandoz
First posted
Mar 19, 2009
Start date
Nov 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Mar 29, 2017

Study contacts

Soran Hong, M.D.
principal investigator · Novum Pharmaceutical Research Services
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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