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 | Completed

• 1 other identifier: 013-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oral bioavailabilities: Maximum Concentration (Cmax) of eperisone and diclofenac fixed dose capsules versus eperisone & diclofenac tablets

  Compare single-dose oral bioavailabilities (Cmax) of eperisone and diclofenac fixed dose capsules with eperisone \& diclofenac tablets. Cmax is defined as the maximum observed concentration in plasma.

  12 hours post dose

Secondary Outcomes (1)

• Safety & tolerability (total number of subjects reporting adverse events) of single dose of fixed dose combination of eperisone and diclofenac in fasting conditions

  10 days

Study Arms (2)

1

EXPERIMENTAL

Drug: eperisone hydrochloride plus diclofenac sodium capsule

2

ACTIVE COMPARATOR

Drug: eperisone hydrochloride tablet and diclofenac sodium tablet

Interventions

eperisone hydrochloride plus diclofenac sodium capsule DRUG

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

1

eperisone hydrochloride tablet and diclofenac sodium tablet DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal healthy human adult male volunteers between 18-45 years (both ages inclusive) of age, who have given written informed consent and are willing to participate in the study.
• Volunteer having Body Mass Index of 18.50 to 24.90 Kg/m2 (both inclusive).
• Volunteer with no evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study
• Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study.
• Volunteer with negative test for alcohol and drugs of abuse, hepatitis B and C and who is negative or nonreactive for antibodies to human immunodeficiency virus (HIV) 1 and 2 and rapid plasma reagin (RPR).
• Volunteer having a 12 lead electrocardiogram (ECG) recording within normal limits.
• Volunteer with normal chest X-ray taken within 6 months before the day of dosing.
• Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.

You may not qualify if:

• Volunteer who is allergic to eperisone and/or diclofenac or any component of the formulation and to any other related drug.
• Volunteer with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
• More specifically, volunteer with history or presence of the following significant conditions:
• Alcohol dependence, alcohol abuse or drug abuse within the past one year, recent or current alcohol abuse (\> 5 units/week, 1 unit= 10 mL or 8 g of pure alcohol) or suspected abuse.
• History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
• Asthma, urticaria or other allergic type reactions after taking any medication.
• Clinically significant illness within 4 weeks before the start of the study.
• Hypersensitivity to heparin.
• History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
• History of Vascular collapse.
• Volunteer who is scheduled for surgery within 7 days after study completion.
• Volunteer who, through completion of any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
• Volunteer who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin) within 14 days prior to administration of IP in period 1, including topical medication meant for systemic absorption.
• Volunteer who was hospitalized within 28 days prior to administration of the study medication.
• Volunteer with pulse rate less than 60/min or more than 100/min.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Manipal AcuNova KH Clinical Research Center

Manipal, Karnataka, 576 104, India

Location

MeSH Terms

Interventions

eperisone; Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Suyog Mehta

  General Manager Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, Mumbai, MS, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 1, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

IN (1)