HealthyNCT00775905
Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
A study testing amlodipine 10 mg tablet 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 rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- amlodipine 10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Oct 2005
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra- uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy?
- Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study.
- Has s/he provided written informed consent?
- A no answer to any of the above questions indicated that the individual was ineligible for enrollment
Who cannot join
- Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? •
- Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation?
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- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
- Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fasted Subjects.
The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects.
Read the detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer Inc USA, in healthy, adult, human, subjects under fasting conditions
- Conditions
- Healthy
- Being tested
- amlodipine 10 mg tablet
- Keywords
- Bioequivalence amlodipine tablets fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine 10 mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | amlodipine 10 mg tablets of Ranbaxy Receives: Drug: amlodipine 10 mg tablet |
| 2 | Active comparator | Norvasc® 10 mg tablets Receives: Drug: amlodipine 10 mg tablet |
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 startJul 2005
- Primary completionAug 2005
- Study completionOct 2005
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775905
- Sponsor's protocol ID
- 50365
- Status last verified
- Oct 2008
- First submitted
- 16 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
- The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fasted Subjects.
- ClinicalTrials.gov ID
- NCT00775905
- Acronym / sponsor ID
- 50365
- Conditions
- Healthy
- Keywords
- Bioequivalence amlodipine tablets fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Oct 2005 (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 rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects.
Detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer Inc USA, in healthy, adult, human, subjects under fasting conditions
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amlodipine 10 mg tabletamlodipine 10 mg tablets of Ranbaxy |
| 2 | Active comparator | Drug: amlodipine 10 mg tabletNorvasc® 10 mg tablets |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra- uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy?
- Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study.
- Has s/he provided written informed consent?
- A no answer to any of the above questions indicated that the individual was ineligible for enrollment
Key exclusion criteria (11 listed)
- Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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 |
|---|---|---|
| amlodipine 10 mg tablet | 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 amlodipine 10 mg tablet 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 4 inclusion and 11 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.