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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IPCA Laboratories Ltd.
• Treatments: Etodolac

Criteria

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.