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 Fas

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Diclofenac; Eperisone

Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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:

1. 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.

2. History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.

3. Asthma, urticaria or other allergic type reactions after taking any medication.

4. Clinically significant illness within 4 weeks before the start of the study.

5. 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.

• Volunteer with history of difficulty in swallowing.

• Volunteer who has unsuitable veins for repeated venipuncture.

• Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study.

Volunteer who has

• Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg

• Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.