FedPhase 1NCT01722110
Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition
A Phase 1 study testing Indomethacin Extended-Release Capsules USP 75 mg and Indomethacin Extended Release Capsules USP 75 mg in people with Fed, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, 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 normal, healthy, adult, male and female 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
- Fed
- What is being tested?
- Indomethacin Extended-Release Capsules USP 75 mg and Indomethacin Extended Release Capsules USP 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2012to Jun 2012
- 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
- Male and non pregnant female human subjects, age in the range of 18 - 45 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis and 12 lead ECG.
- Subject's willing to give written informed consent.
- Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
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- No history of significant alcoholism.
- No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
- Non-smokers were included.
Who cannot join
- Known history of hypersensitivity to Indomethacin or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
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- History of malignancy or other serious diseases.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- Found positive in breath alcohol test.
- Found positive in urine test for drug abuse.
- History of problem in swallowing.
- Any contraindication to blood sampling.
- Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
- Lactating women (currently breast feeding).
- Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) were acceptable. Use of hormonal contraceptives either oral or implants.
- Female subjects whose menstruation cycle coincided with the study periods.
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Lab (I) Pvt. Ltd.
Navi Mumbai, Maharashtra, 400 709
About this study
Official title: A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, 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 normal, healthy, adult, male and female human subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in a randomized crossover study.
The study was conducted with 32 healthy adult subjects. In each study period, a single 75 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 at least 7 days between administrations of study drug in each study period.
- Conditions
- Fed
- Being tested
- Indomethacin Extended-Release Capsules USP 75 mg, Indomethacin Extended Release Capsules USP 75 mg
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin Extended-Release Capsules USP 75 mgDrug
Also called Test Product
75 mg tablet once a day
Indomethacin Extended Release Capsules USP 75 mgDrug
75 mg tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin Extended-Release Capsules USP 75 mg | Experimental | Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India Receives: Drug: Indomethacin Extended-Release Capsules USP 75 mg |
| Indomethacin Extended Release Capsules USP 75 mg | Active comparator | Indomethacin Extended Release Capsules USP 75 mg of Epic Pharma, USA. Receives: Drug: Indomethacin Extended Release Capsules USP 75 mg |
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 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs post dose.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FedStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Suhas Khandave, M.D., Principal investigator, Accutest Research Lab (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722110
- Sponsor's protocol ID
- Ipca/ARL-10/436
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2012
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01722110
- Acronym / sponsor ID
- Ipca/ARL-10/436
- Conditions
- Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Nov 2012 (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 randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, 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 normal, healthy, adult, male and female human subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in a randomized crossover study.
The study was conducted with 32 healthy adult subjects. In each study period, a single 75 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 at least 7 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 |
|---|---|---|
| Indomethacin Extended-Release Capsules USP 75 mg | Experimental | Drug: Indomethacin Extended-Release Capsules USP 75 mgIndomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India |
| Indomethacin Extended Release Capsules USP 75 mg | Active comparator | Drug: Indomethacin Extended Release Capsules USP 75 mgIndomethacin Extended Release Capsules USP 75 mg of Epic Pharma, USA. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and non pregnant female human subjects, age in the range of 18 - 45 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis and 12 lead ECG.
- Subject's willing to give written informed consent.
Key exclusion criteria (17 listed)
- Known history of hypersensitivity to Indomethacin or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
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 |
|---|---|---|
| Indomethacin Extended-Release Capsules USP 75 mgAlso: Test Product75 mg tablet once a day | Drug | Indomethacin Extended-Release Capsules USP 75 mg |
| Indomethacin Extended Release Capsules USP 75 mg75 mg tablet once a day | Drug | Indomethacin Extended Release Capsules USP 75 mg |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 2 months
Sampling Hours: Pre-dose and at 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs 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 6 Nov 2012.
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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. Suhas Khandave, M.D. principal investigator
Accutest Research Lab (I) 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 Indomethacin Extended-Release Capsules USP 75 mg and Indomethacin Extended Release Capsules USP 75 mg in people with Fed, 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 9 inclusion and 17 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 6 Nov 2012. 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: 2 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 6 Nov 2012.