Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition

An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover, Oral Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA in Healthy, Adult, Human Subjects Under Fasting Condition.

This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy, adult human subjects.

Study Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Drug: Etodolac Extended Release Tablets USP 600mg; Drug: Etodolac Extended Release Tablets 600mg

Detailed Description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA under fasting condition in healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 36 healthy adult subjects. In each study period, a single 600 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 15 days including washout period of 11 days between administrations of study drug in each study period.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 015
      • Veeda Clinical Research Pvt. Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and non-pregnant female subjects within the age range of 18 to 45 years (both inclusive), at the time of dosing.
2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable reference range.
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken within 6 months prior to the dosing of Period 01.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to protocol requirements and to provide written informed consent.
9. Subjects having negative beta-hCG Pregnancy test (only for female subjects).

10. For Female Subjects:

    • Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
    • Postmenopausal for at least 1 years, or if less than 1 years, then following acceptable contraceptive measures as mentioned above
    • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. Hypersensitivity to Etodolac or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. History or presence of significant alcoholism or drug abuse.
4. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
5. History or presence of significant asthma, urticaria or other allergic reactions.
6. History or presence of significant gastric and/or duodenal ulceration.
7. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
8. History or presence of cancer.
9. Difficulty with donating blood.
10. Difficulty in swallowing solids like tablets or capsules.
11. Use of any prescribed medication or OTC medical products during last two weeks prior to dosing in period 01.
12. Major illness during 3 months before screening.
13. Participation in a drug research study within past 3 months.
14. Donation of blood in the past 3 months before screening.
15. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing.
16. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
17. History or presence of significant easy bruising or bleeding.
18. History or presence of significant recent trauma.
19. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
20. Female subjects who are currently on breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Etodolac Extended Release Tablets 600mg; Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA	Drug: Etodolac Extended Release Tablets USP 600mg; Etodolac Extended Release Tablets USP 600mg once a day; Other Names: Test product; Drug: Etodolac Extended Release Tablets 600mg; Etodolac Extended Release Tablets 600mg once a day; Other Names: Reference Product
Experimental: Etodolac Extended Release Tablets USP 600mg; Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India	Drug: Etodolac Extended Release Tablets USP 600mg; Etodolac Extended Release Tablets USP 600mg once a day; Other Names: Test product; Drug: Etodolac Extended Release Tablets 600mg; Etodolac Extended Release Tablets 600mg once a day; Other Names: Reference Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence is based on Cmax and AUC parameters.	Sampling hours: Pre-dose and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post dose.	4 Months

Collaborators and Investigators

• Sponsor: IPCA Laboratories Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 10, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etodolac
• Other Study ID Numbers: Ipca/11-VIN-413