Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition
Information source: IPCA Laboratories Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Etodolac Capsules USP 300 mg (Drug); Etodolac (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: IPCA Laboratories Ltd. Official(s) and/or principal investigator(s): Dr. Hardik Dave, M.B.B.S., Principal Investigator, Affiliation: Veeda Clinical Research Pvt. Ltd.
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CmaxAUC
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Veeda Clinical Research Pvt. Ltd., Ahmedabad, Gujarat, India
Additional Information
Starting date: October 2012
Last updated: December 12, 2012
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