Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT01749228
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Etodolac Capsules USP 300 mg
Drug: Etodolac
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover, Oral Bioequivalence Study of Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India and Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA in Healthy, Adult, Human Subjects Under Fed Condition.

Resource links provided by NLM:


Further study details as provided by IPCA Laboratories Ltd.:

Primary Outcome Measures:
  • Cmax [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.

  • AUC [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours.


Enrollment: 36
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etodolac Capsules USP 300 mg
Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India
Drug: Etodolac Capsules USP 300 mg
300 mg capsule once a day
Other Name: Test Product
Active Comparator: Etodolac Capsules USP 300mg
Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA
Drug: Etodolac
500 mg tablet once a day
Other Name: Reference Product

Detailed Description:

Objective of this pivotal study was to assess the bioequivalence between Test Product: Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA, under fed 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 300 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 10 days including washout period of 7 days between administrations of study drug in each study period.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749228

Locations
India
Veeda Clinical Research Pvt. Ltd.
Ahmedabad, Gujarat, India
Sponsors and Collaborators
IPCA Laboratories Ltd.
Investigators
Principal Investigator: Dr. Hardik Dave, M.B.B.S. Veeda Clinical Research Pvt. Ltd.
  More Information

No publications provided

Responsible Party: IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01749228     History of Changes
Other Study ID Numbers: Ipca/VIN-11/416
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: India: Ministry of Health
United States: Institutional Review Board

Keywords provided by IPCA Laboratories Ltd.:
Fed

Additional relevant MeSH terms:
Etodolac
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014