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Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition

NCT01741623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-12-05

No results posted yet for this study

Summary

This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult human subjects.

Conditions

  • Fasting

Interventions

DRUG

Bisoprolol Fumarate Tablet 10 mg

10 mg tablet once a day

DRUG

Bisoprolol

10 mg tablet once a day

Sponsors & Collaborators

  • IPCA Laboratories Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Rupesh Vala, M.B.B.S. · Accutest Research Lab (I) 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
2012-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01741623 on ClinicalTrials.gov