HealthyNCT00775359
Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions
A study testing Fenofibrate 160 mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed 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?
- Fenofibrate 160 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Oct 2002
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject candidates must fulfill the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male and female volunteers, 18-55 years of age;
- Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with no clinically abnormal laboratories and ECGs, as deemed by the principal investigator;
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
- Surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof is required for the hysterectomy and oophorectomy;
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- IUD in place for at least 3 months;
- Barrier methods with spermicide (condom, diaphragm) for at least 14 days prior to the start of the study and throughout the study;
- Surgical sterilization of the partner (vasectomy for 6 months minimum);
- Hormonal contraceptives for at least 3 months prior to the start of the study. Other birth control methods may be deemed acceptable.
- Postmenopausal women with amenorrhea for at least 2 years;
- Voluntary consent to participate in the study.
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past 2 years;
- hypersensitivity or idiosyncratic reaction to fenofibrate or other lipid regulating agents.
- Female subjects who are pregnant or lactating.
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- Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dosing.
- Subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study.
- Subjects who have made a plasma donation within 7 days prior to the study.
- Subjects who have participated in another clinical trial within 30 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Abbott (TriCor®) 160 mg Fenofibrate Tablets in Healthy Adult Volunteers Under Fed Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.
Read the detailed description
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male and female volunteers A total of 23 subjects (16 males and 7 females) completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects returned for all subsequent blood draws. Doses were separated by a washout period of 10 days.
Of the 24 healthy adult male and female volunteers enrolled in the study, 23 subjects (16 males and 7 females) completed the clinical phase of the study. Subject No. 10 failed to return for Period 2 check-in.
- Conditions
- Healthy
- Being tested
- Fenofibrate 160 mg tablets
- Keywords
- bioequivalence fenofibrate tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate 160 mg tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fenofibrate 160mg Tablets of Ranbaxy Receives: Drug: Fenofibrate 160 mg tablets |
| 2 | Active comparator | TriCor® 160 mg Fenofibrate Tablets Receives: Drug: Fenofibrate 160 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startAug 2002
- Primary completionSep 2002
- Study completionOct 2002
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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775359
- Sponsor's protocol ID
- AA01824
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Abbott (TriCor®) 160 mg Fenofibrate Tablets in Healthy Adult Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00775359
- Acronym / sponsor ID
- AA01824
- Conditions
- Healthy
- Keywords
- bioequivalence fenofibrate tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Sep 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 20 Oct 2008 (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 was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.
Detailed description
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male and female volunteers A total of 23 subjects (16 males and 7 females) completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects returned for all subsequent blood draws. Doses were separated by a washout period of 10 days.
Of the 24 healthy adult male and female volunteers enrolled in the study, 23 subjects (16 males and 7 females) completed the clinical phase of the study. Subject No. 10 failed to return for Period 2 check-in.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fenofibrate 160 mg tabletsFenofibrate 160mg Tablets of Ranbaxy |
| 2 | Active comparator | Drug: Fenofibrate 160 mg tabletsTriCor® 160 mg Fenofibrate Tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject candidates must fulfill the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- Healthy adult male and female volunteers, 18-55 years of age;
- Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- Medically healthy subjects with no clinically abnormal laboratories and ECGs, as deemed by the principal investigator;
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
Key exclusion criteria (10 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant: cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, history or presence of:
- Female subjects who are pregnant or lactating.
- Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first 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 |
|---|---|---|
| Fenofibrate 160 mg tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 20 Oct 2008.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate 160 mg tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 10 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 20 Oct 2008. 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 United States. 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.
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. 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 20 Oct 2008.