FastingPhase 1NCT01831687
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition
A Phase 1 study testing Etodolac Extended Release Tablets USP 600mg and Etodolac Extended Release Tablets 600mg in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
Trial 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 fed condition in healthy, adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Etodolac Extended Release Tablets USP 600mg and Etodolac Extended Release Tablets 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and non-pregnant female subjects (age range of 18 to 45 years).
- 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)and normal chest X-Ray (P/A view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Subjects having negative alcohol breath test.
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- 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).
Who cannot join
- 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.
- History or presence of significant asthma, urticaria or other allergic reactions.
- History or presence of significant gastric and/or duodenal ulceration.
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- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- 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.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- Female subjects who are currently on breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 Fed 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 fed condition in healthy, adult human subjects.
Read the 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 600 mg of Teva Pharmaceutical Ind. 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 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.
- Conditions
- Fasting
- Being tested
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etodolac Extended Release Tablets USP 600mgDrug
Also called Test product
Etodolac Extended Release Tablets USP 600mg once a day
Etodolac Extended Release Tablets 600mgDrug
Also called Reference product
Etodolac Extended Release Tablets 600mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Etodolac Extended Release Tablets 600mg | Active comparator | Etodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA Receives: 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 Receives: Drug: Etodolac Extended Release Tablets USP 600mg; Drug: Etodolac Extended Release Tablets 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Hardik Dave, M.B.B.S, Principal investigator, Veeda Clinical Research Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831687
- Sponsor's protocol ID
- Ipca/11-VIN-414
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Fed Condition
- ClinicalTrials.gov ID
- NCT01831687
- Acronym / sponsor ID
- Ipca/11-VIN-414
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fed condition in healthy, adult human subjects.
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 600 mg of Teva Pharmaceutical Ind. 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etodolac Extended Release Tablets 600mg | Active comparator | Drug: Etodolac Extended Release Tablets USP 600mg, Drug: Etodolac Extended Release Tablets 600mgEtodolac Extended Release Tablets 600mg of Teva Pharmaceutical Ind. Ltd., USA |
| Etodolac Extended Release Tablets USP 600mg | Experimental | Drug: Etodolac Extended Release Tablets USP 600mg, Drug: Etodolac Extended Release Tablets 600mgEtodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male and non-pregnant female subjects (age range of 18 to 45 years).
- 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)and normal chest X-Ray (P/A view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
Key exclusion criteria (20 listed)
- 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.
- History or presence of significant asthma, urticaria or other allergic reactions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etodolac Extended Release Tablets USP 600mgAlso: Test productEtodolac Extended Release Tablets USP 600mg once a day | Drug | Etodolac Extended Release Tablets 600mg, Etodolac Extended Release Tablets USP 600mg |
| Etodolac Extended Release Tablets 600mgAlso: Reference productEtodolac Extended Release Tablets 600mg once a day | Drug | Etodolac Extended Release Tablets 600mg, Etodolac Extended Release Tablets USP 600mg |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 1 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Hardik Dave, M.B.B.S principal investigator
Veeda Clinical Research Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etodolac Extended Release Tablets USP 600mg and Etodolac Extended Release Tablets 600mg in people with Fasting, run by IPCA Laboratories Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence is based on Cmax and AUC parameters. (time frame: 1 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.