HealthyNCT02306902
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions
A study testing fenofibrate and ANTARA® (fenofibrate) in people with Healthy, run by Ranbaxy Laboratories Limited.
Trial summary
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules 130 mg manufactured by Ethypharm Industries… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fenofibrate and ANTARA® (fenofibrate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2010
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers who met the following criteria were included in the study
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance
- Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- Had a non-vegetarian dietary habit.
Who cannot join
- Subject had history of hypersensitivity to fenofibrate or any related drug or to any other drug.
- Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
- Subjects with history of unexplained persistent liver function abnormality.
- Subjects with history of preexisting gallbladder disease.
- Subject had history of myalgia, muscle tenderness or weakness or myopathy
- Subject had any evidence of organ dysfunction or any clinically significant deviation from the normal in physical or clinical determinations.
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- Clinically abnormal ECG or Chest X-ray, or hematological and biochemical parameters which was/were outside acceptable limits and was judged clinically significant by investigator.
- Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C Viruses of syphilis infection.
- Investigations with urine samples of the subject showed clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4 /HPF), glucose (Positive) or Protein (Positive).
- Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma, any serious, potentially life-threatening illness.
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.
- Subject was a regular smoker, who smoked 10 or more cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- Subject had history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining for the duration of each study period.
- Use of any regular medication (OTC or prescription) or any drug metabolizing enzyme within 30 days prior to Day 1 of this study.
- Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I dosing).
- Subject had donated and/or lost more than 350 mL of blood in the past 3 months, including blood loss in this study.
- Consumption of alcohol for 48 hours prior to admission.
- Consumption of grapefruit juice and or grape fruit supplements containing products for 48 hours prior to admission.
- Subject had problem(s) in complying with the study protocol.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study Comparing Fenofibrate Capsule 130 mg of Ohm Laboratories Inc., USA (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With Antara® Capsule 130 mg (Containing Fenofibrate 130 mg) of Oscient Pharmaceutical Corporation, USA in Healthy, Adult, Male Human Subjects Under Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules 130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed condition.
Read the detailed description
The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) in urine prior to admission in each period.
Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of fenofibrate capsules 130 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low light condition. The pre-dose blood samples in each period were collected in duplicate (2 x 5 mL), within a period of 1.5 hour before dosing. Post-dose samples were generally collected within 2 minutes of the scheduled time.
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis at screening). Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.
- Conditions
- Healthy
- Being tested
- fenofibrate, ANTARA® (fenofibrate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrateDrug
130mg, Capsules
ANTARA® (fenofibrate)Drug
130mg, Capsules
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Fenofibrate Capsules, USP 130 mg Receives: Drug: fenofibrate |
| Reference | Active comparator | ANTARA® (fenofibrate) Capsules 130 mg Receives: Drug: ANTARA® (fenofibrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of fenofibric acid
Measured: 0-96 hrs
Peak Plasma Concentration (Cmax) of fenofibric acid
Measured: 0-96 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionApr 2010
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306902
- Sponsor's protocol ID
- 243_FENOF_09
- Status last verified
- Dec 2014
- First submitted
- 24 Nov 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study Comparing Fenofibrate Capsule 130 mg of Ohm Laboratories Inc., USA (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With Antara® Capsule 130 mg (Containing Fenofibrate 130 mg) of Oscient Pharmaceutical Corporation, USA in Healthy, Adult, Male Human Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT02306902
- Acronym / sponsor ID
- 243_FENOF_09
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 3 Dec 2014 (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 study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories Inc, NJ 08901 with ANTARA® (fenofibrate) capsules 130 mg manufactured by Ethypharm Industries Saint Cloud, France for Oscient Pharmaceuticals Corp. Waltham, MA 02451 in healthy, adult, male, human subjects under fed condition.
Detailed description
The subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) in urine prior to admission in each period.
Following an overnight fast of at least 10 hour, a high-fat high calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of fenofibrate capsules 130 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
Blood samples were collected at pre-dose and at 1.000, 2.000, 3.000, 4.000, 4.500, 5.000, 5.500, 6.000, 6.500, 7.000, 7.500, 8.000, 8.500, 9.000, 9.500, 10.000, 11.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post dose in each period under low light condition. The pre-dose blood samples in each period were collected in duplicate (2 x 5 mL), within a period of 1.5 hour before dosing. Post-dose samples were generally collected within 2 minutes of the scheduled time.
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis at screening). Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: fenofibrateFenofibrate Capsules, USP 130 mg |
| Reference | Active comparator | Drug: ANTARA® (fenofibrate)ANTARA® (fenofibrate) Capsules 130 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Volunteers who met the following criteria were included in the study
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance
- Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
Key exclusion criteria (19 listed)
- Subject had history of hypersensitivity to fenofibrate or any related drug or to any other drug.
- Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
- Subjects with history of unexplained persistent liver function abnormality.
- Subjects with history of preexisting gallbladder disease.
- Subject had history of myalgia, muscle tenderness or weakness or myopathy
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 |
|---|---|---|
| fenofibrate130mg, Capsules | Drug | Test |
| ANTARA® (fenofibrate)130mg, Capsules | Drug | Reference |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of fenofibric acid
Time frame: 0-96 hrs
Peak Plasma Concentration (Cmax) of fenofibric acid
Time frame: 0-96 hrs
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 3 Dec 2014.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fenofibrate and ANTARA® (fenofibrate) in people with Healthy, run by Ranbaxy Laboratories Limited.
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 7 inclusion and 19 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Area under the plasma concentration versus time curve (AUC) of fenofibric acid (time frame: 0-96 hrs). The study lists 2 primary outcomes in all. 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 3 Dec 2014.