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

NCT01827865 | Completed Phase 1 DMC

• 1 other identifier: Ipca/11-VIN-413
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Etodolac Extended Release Tablets 600mg

ACTIVE COMPARATOR

Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA

Drug: Etodolac Extended Release Tablets USP 600mg; Drug: Etodolac Extended Release Tablets 600mg

Etodolac Extended Release Tablets USP 600mg

EXPERIMENTAL

Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India

Drug: Etodolac Extended Release Tablets USP 600mg; Drug: Etodolac Extended Release Tablets 600mg

Interventions

Etodolac Extended Release Tablets USP 600mg DRUG

Etodolac Extended Release Tablets USP 600mg once a day

Also known as: Test product

Etodolac Extended Release Tablets 600mg; Etodolac Extended Release Tablets USP 600mg

Etodolac Extended Release Tablets 600mg DRUG

Etodolac Extended Release Tablets 600mg once a day

Also known as: Reference Product

Etodolac Extended Release Tablets 600mg; Etodolac Extended Release Tablets USP 600mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and non-pregnant female subjects within the age range of 18 to 45 years (both inclusive), at the time of dosing.
• 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.
• Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable reference range.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken within 6 months prior to the dosing of Period 01.
• Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative alcohol breath test.
• Subjects willing to adhere to protocol requirements and to provide written informed consent.
• 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).

You may not qualify if:

• Hypersensitivity to Etodolac or related class of drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse.
• History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
• History or presence of significant asthma, urticaria or other allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
• History or presence of cancer.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Use of any prescribed medication or OTC medical products during last two weeks prior to dosing in period 01.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.
• Donation of blood in the past 3 months before screening.
• Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Veeda Clinical Research Pvt. Ltd.

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Dr. Hardik Dave, M.B.B.S

  Veeda Clinical Research Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 10, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

IN (1)