HealthyNCT02311530
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fed Conditions
A study testing Felodipine and Felodipine (Plendil®) 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 felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL® extended release… 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?
- Felodipine and Felodipine (Plendil®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2008
- 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 their 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 diet habit.
Who cannot join
- History of known hypersensitivity to Felodipine, related drugs and or any other drug
- Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I.
- History of chronic headache, dizziness and syncope.
- History of peripheral edema.
- History of grapefruit juice and / or grapefruit supplements intake in past 48 hours.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
Show all 19Show fewer
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
- History of any psychiatric illness which might impair the ability to provide written informed consent.
- Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of the study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of the study.
- Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Felodipine Extended Release Tablet (Containing Felodipine 10 mg) of OHM Laboratories Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc) With PLENDIL® Extended Release Tablet (Containing Felodipine 10 mg) Manufactured by Merck & Co. Inc. for AstraZeneca in Healthy, Adult, Male, Human Subjects Under Fed Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck \& Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
Read the detailed description
All the subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) prior to admission in each period. Only subjects with negative results in these tests were preceded for further activities.
Following an overnight fast of at least 10 hour, a high-fat highcalorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of felodipine extended release tablets 10 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.
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 baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
- Conditions
- Healthy
- Being tested
- Felodipine, Felodipine (Plendil®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FelodipineDrug
Extended Release Tablets, 10mg
Felodipine (Plendil®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Felodipine Extended Release Tablets USP 10 mg Receives: Drug: Felodipine |
| Reference | Active comparator | Plendil® Extended release tablets 10 mg Receives: Drug: Felodipine (Plendil®) |
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 Felodipine
Measured: 0-72 hrs
Peak Plasma Concentration (Cmax) of Felodipine
Measured: 0-72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionDec 2008
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
- 80 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
- NCT02311530
- Sponsor's protocol ID
- 244_FELOD_08
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 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 Felodipine Extended Release Tablet (Containing Felodipine 10 mg) of OHM Laboratories Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc) With PLENDIL® Extended Release Tablet (Containing Felodipine 10 mg) Manufactured by Merck & Co. Inc. for AstraZeneca in Healthy, Adult, Male, Human Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT02311530
- Acronym / sponsor ID
- 244_FELOD_08
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 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 felodipine extended release tablets USP 10 mg (containing felodipine 10 mg) manufactured by OHM Laboratories Inc., NJ, 08901 with PLENDIL® extended release tablets 10 mg (containing felodipine 10 mg) manufactured by Merck \& Co. Inc. Whitehouse Station, NJ 08889 USA for AstraZeneca LP Wilmington, DE 19850 in healthy, adult, male, human subjects under fed condition.
Detailed description
All the subjects were subjected to breath test for alcohol and test for drugs of abuse (opioids and cannabinoids) prior to admission in each period. Only subjects with negative results in these tests were preceded for further activities.
Following an overnight fast of at least 10 hour, a high-fat highcalorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of felodipine extended release tablets 10 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.
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 baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) 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: FelodipineFelodipine Extended Release Tablets USP 10 mg |
| Reference | Active comparator | Drug: Felodipine (Plendil®)Plendil® Extended release tablets 10 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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 their 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.
Key exclusion criteria (19 listed)
- History of known hypersensitivity to Felodipine, related drugs and or any other drug
- Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I.
- History of chronic headache, dizziness and syncope.
- History of peripheral edema.
- History of grapefruit juice and / or grapefruit supplements intake in past 48 hours.
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 |
|---|---|---|
| FelodipineExtended Release Tablets, 10mg | Drug | Test |
| Felodipine (Plendil®) | Drug | Reference |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of Felodipine
Time frame: 0-72 hrs
Peak Plasma Concentration (Cmax) of Felodipine
Time frame: 0-72 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 8 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 Felodipine and Felodipine (Plendil®) 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 6 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 8 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 Felodipine (time frame: 0-72 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 8 Dec 2014.