HealthyPhase 1NCT01161134
Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition
A Phase 1 study testing Meloxicam in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meloxicam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Nov 2004
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must be a healthy male or female volunteer.If the volunteer is female. she must demonstrate β-CG levels consistent with the nongravid state at the medical screening visit and at check-in for Period 1 and agree to remain abstinent or use double-barrier contraception (partner using condom and female volunteer using diaphragm, contraceptive sponge, spermicide, or IUD). If the female is post-menopausal or is surgically sterile, she is exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If cessation of menses is within 18 months, FSH and/or LH must be documented prestudy as elevated into the postmenopausal range.).
- The subject must be between the ages of 18 - 55 years old (inclusive).
- The Subject's body mass index (BMI) must be within 19.0 - 30.0 (Kg/m2).
- The subject must be a non-smoker and not using any nicotine products.
- The subject must sign the written consent form (Research Subject Information and Consent Form) prior to study entry.
- The subject must have clinically acceptable results from the screening procedure including blood pressure, heart rate, ECG, physical exam, medical history, hematology, biochemistry, urinalysis. and infection screen (Hepatitis B Antigen, Hepatitis C Antibody, HIV)
Who cannot join
- Subjects with a history of clinically significant gastro-intestinal, dermatological, cardiovascular, renal, hematological, neurological, hepatic, pulmonary, or endocrine disease in the last 12 months.
- Subjects determined by the Investigator to have any medical condition which may affect the absorption, distribution, metabolism or excretion of the investigational product, or that could jeopardize their health or prejudice the results (e.g. history of surgery of the gastro-intestinal tract, except for appendectomy).
- Subjects with a known allergy to meloxicam (Mobic) or other nonsteroidal anti-inflammatory drugs (NSAIDS) [e.g. Motrin® (ibuprofen), Celebrex® (celecoxib). Vioxx® (rofecoxib). Naprelan® and Anaprox®, (naproxen sodium), Lodine® (etodolac), Cataflam® (diclofenac potassium). Voltaren® and Arthrotec®(diclofenac sodium), etc.].
- Females who are pregnant, breastfeeding, or are likely to become pregnant.
- Subjects with any clinically significant illness within four weeks prior to Period 1 dosing.
- Subjects with a positive saliva alcohol test at check-in for any period.
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- Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
- Subjects who have used any prescription medication within 14 days of Period 1 dosing or over-the-counter medication within 14 days of Period 1 dosing.
- Subjects deemed uncooperative or noncompliant.
- Subjects who have consumed alcohol within 48 hours prior to Period 1 and Period 2 dosing.
- Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to Period 1 dosing.
- Subjects who have consumed food or beverages containing grapefruit (e.g. fresh, Canned, or frozen) within 14 days prior to the administration of the study medication.
- Subjects who have had an abnormal diet within 30 days prior to Period 1 dosing.
- Subjects who have participated in an investigational drug study or who have donated more than 100 mL of blood within 30 days prior to Period 1 dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Bioavailability Study of Meloxicam 15 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics) Vs. Mobic® 15 mg Tablets (Boehringer Ingelheim Pharmaceuticals Inc.,Usa) in Healthy Male And/Or Female Volunteers Under Fasting Conditions-P1cx04001
The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.
Read the detailed description
Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female subjects participated in an open label, two-period, two-sequence, two- treatment,single dose, two-way crossover study with at least 14 days washout between doses conducted under fasting conditions.
- Conditions
- Healthy
- Being tested
- Meloxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
Also called Mobic Tablets 15 mg
Meloxicam Tablets 15 mg
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Experimental | Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Receives: Drug: Meloxicam |
| Mobic | Active comparator | Mobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence on Cmax and AUC parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startSep 2004
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deepen M Patel, M.D., C.C.F.P., Principal investigator, Allied Research International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161134
- Sponsor's protocol ID
- P1CX04001
- Status last verified
- Aug 2004
- First submitted
- 12 Jul 2010
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Study of Meloxicam 15 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics) Vs. Mobic® 15 mg Tablets (Boehringer Ingelheim Pharmaceuticals Inc.,Usa) in Healthy Male And/Or Female Volunteers Under Fasting Conditions-P1cx04001
- ClinicalTrials.gov ID
- NCT01161134
- Acronym / sponsor ID
- P1CX04001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 13 Jul 2010 (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.
The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.
Detailed description
Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female subjects participated in an open label, two-period, two-sequence, two- treatment,single dose, two-way crossover study with at least 14 days washout between doses conducted under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | Experimental | Drug: MeloxicamMeloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited |
| Mobic | Active comparator | Drug: MeloxicamMobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject must be a healthy male or female volunteer.If the volunteer is female. she must demonstrate β-CG levels consistent with the nongravid state at the medical screening visit and at check-in for Period 1 and agree to remain abstinent or use double-barrier contraception (partner using condom and female volunteer using diaphragm, contraceptive sponge, spermicide, or IUD). If the female is post-menopausal or is surgically sterile, she is exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If cessation of menses is within 18 months, FSH and/or LH must be documented prestudy as elevated into the postmenopausal range.).
- The subject must be between the ages of 18 - 55 years old (inclusive).
- The Subject's body mass index (BMI) must be within 19.0 - 30.0 (Kg/m2).
- The subject must be a non-smoker and not using any nicotine products.
- The subject must sign the written consent form (Research Subject Information and Consent Form) prior to study entry.
Key exclusion criteria (14 listed)
- Subjects with a history of clinically significant gastro-intestinal, dermatological, cardiovascular, renal, hematological, neurological, hepatic, pulmonary, or endocrine disease in the last 12 months.
- Subjects determined by the Investigator to have any medical condition which may affect the absorption, distribution, metabolism or excretion of the investigational product, or that could jeopardize their health or prejudice the results (e.g. history of surgery of the gastro-intestinal tract, except for appendectomy).
- Subjects with a known allergy to meloxicam (Mobic) or other nonsteroidal anti-inflammatory drugs (NSAIDS) [e.g. Motrin® (ibuprofen), Celebrex® (celecoxib). Vioxx® (rofecoxib). Naprelan® and Anaprox®, (naproxen sodium), Lodine® (etodolac), Cataflam® (diclofenac potassium). Voltaren® and Arthrotec®(diclofenac sodium), etc.].
- Females who are pregnant, breastfeeding, or are likely to become pregnant.
- Subjects with any clinically significant illness within four weeks prior to Period 1 dosing.
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 |
|---|---|---|
| MeloxicamAlso: Mobic Tablets 15 mgMeloxicam Tablets 15 mg | Drug | Meloxicam, Mobic |
Primary outcome
Bioequivalence on Cmax and AUC parameters
Time frame: 4 months
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 13 Jul 2010.
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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.
Deepen M Patel, M.D., C.C.F.P. principal investigator
Allied Research International Inc.
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 Meloxicam in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
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 6 inclusion and 14 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 13 Jul 2010. 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 Canada. 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 on Cmax and AUC parameters (time frame: 4 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 13 Jul 2010.