NCT01306318

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)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of this study is to compare the single-dose oral bioavailabilities of eperisone and diclofenac from Epry-D (containing eperisone hydrochloride 50 mg and diclofenac sodium 50 mg) capsules of Eisai Pharmaceuticals India Private Limited, India with those from Epry (eperisone hydrochloride) 50 mg tablets of Eisai Pharmaceuticals India Pvt. Ltd., and voltaren (diclofenac sodium) 50 mg tablets of Novartis Pharmaceuticals Ltd., India in healthy human adult male subjects under fasting conditions. The secondary objective of this study is to monitor the safety and tolerability of a single dose of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg formulation when administered in healthy human adult male subjects under fasting conditions. The participants will be screened for demographic data, medical history, general physical examination, 12-lead electrocardiogram (ECG), chest X-ray (Posterior to Anterior view), hematology, clinical bio- chemistry, serology, urine analysis, tests for alcohol and drugs of abuse. A total of 24 healthy adult male volunteer participants will be housed in the clinical study facility at least 11 hours before administration of the Investigational Product (IP) and will continue to remain in the clinical study facility for at least 12 hours after administration of the IP in each study period. After overnight fasting for at least 10 hours, either one Epry-D capsule or one Epry 50 mg tablet and one Voltaren 50 mg tablet will be administered orally to each participant in sitting posture, with 240 plus or minus 2 mL of water at room temperature, in each study period, as per the randomization schedule. Administration of the IP will be performed by trained study personnel. Dosing activity will be followed by mouth check to assess the compliance to dosing. A total of 22 (6 mL) blood samples will be collected from each subject in pre-specified vacuum tubes containing K2 EDTA in each study period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-03-01
• Last updated: 2015-11-17

Locations

1 site across 1 country: India