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Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions

NCT01132040 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-05-27

No results posted yet for this study

Summary

The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Primidone

Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mohanlal shiva prasad sayana · Bioserve Clinical Research Pvt. Ltd., Hyderabad, A.P.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • India

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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 NCT01132040 on ClinicalTrials.gov