MedTrace Logo

A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)

NCT01306318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-17

No results posted yet for this study

Summary

The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions.

Conditions

  • Healthy Volunteers

Interventions

DRUG

eperisone hydrochloride plus diclofenac sodium capsule

Single dose of fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given in healthy volunteers in fasting conditions

DRUG

eperisone hydrochloride tablet and diclofenac sodium tablet

Single dose of eperisone hydrochloride 50 mg as tablet formulation and diclofenac sodium 50 mg as tablet formulation to be given in healthy volunteers in fasting conditions

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Suyog Mehta · General Manager Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, Mumbai, MS, India

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
2011-02-28
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • India

Study Locations

More Related Trials

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 NCT01306318 on ClinicalTrials.gov