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Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition

NCT01831674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-04-15

No results posted yet for this study

Summary

The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.

Conditions

  • Fasting

Interventions

DRUG

Metformin Hydrochloride Extended-Release Tablets USP 750

Metformin Hydrochloride Extended-Release Tablets 750 mg once a day

DRUG

GLUCOPHAGE®XR tablet 750 mg

GLUCOPHAGE®XR 750 mg once a day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Hardik Dave, M.B.B.S · Veeda Clinical Research Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831674 on ClinicalTrials.gov