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
Information source: Eisai Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: eperisone hydrochloride plus diclofenac sodium capsule (Drug); eperisone hydrochloride tablet and diclofenac sodium tablet (Drug)
Sponsored by: Eisai Co., Ltd.
Official(s) and/or principal investigator(s):
Suyog Mehta, Study Director, Affiliation: General Manager Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, Mumbai, MS, India
Suyog C Mehta, Phone: +91-22-28579740, Email: email@example.com
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.
Official title: A RANDOMIZED, OPEN LABEL, BALANCED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, SINGLE DOSE, TWO WAY CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY OF EPRY-D (CONTAINING EPERISONE HYDROCHLORIDE 50 MG AND DICLOFENAC SODIUM 50 MG) CAPSULES OF EISAI PHARMACEUTICALS INDIA PRIVATE LIMITED, INDIA WITH EPRY (EPERISONE HYDROCHLORIDE) 50 MG TABLETS OF EISAI PHARMACEUTICALS INDIA PVT. LTD, AND VOVERAN (DICLOFENAC SODIUM) 50 MG TABLETS OF NOVARTIS PHARMACEUTICALS LTD., INDIA IN 24 HEALTHY HUMAN ADULT MALE SUBJECTS, UNDER FASTING CONDITIONS
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: compare single-dose oral bioavailabilities (Cmax) of eperisone and diclofenac fixed dose capsules with eperisone & diclofenac tablets
Secondary outcome: monitor safety & tolerability (total number of subjects reporting adverse events) of single dose of fixed dose combination of eperisone and diclofenac in fasting conditions
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 Voveran (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 said study will be conducted at
Manipal Acunova KH Clinical Research Centre, Manipal, Karnataka State, India. The patients
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 subjects 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 [Test product (A)] or one Epry 50 mg tablet and one Voveran 50 mg tablet
[Reference product (B1 and B2)] will be administered orally to each subject 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.
Minimum age: 18 Years.
Maximum age: 45 Years.
- 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
- 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
- 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
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
- Volunteer who was hospitalized within 28 days prior to administration of the study
- 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
Locations and Contacts
Suyog C Mehta, Phone: +91-22-28579740, Email: firstname.lastname@example.org
Manipal AcuNova KH Clinical Research Center, Manipal, Karnataka 576 104, India; Recruiting
Satish Kumar M C, Phone: +91 9742506686, Email: email@example.com
Starting date: February 2011
Last updated: February 28, 2011