HealthyPhase 1NCT00932880
Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects
A Phase 1 study testing Amlodipine Besylate and Norvasc in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in United States.
Trial summary
Objective: The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy
- What is being tested?
- Amlodipine Besylate and Norvasc
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 45 years
- All sexes
- Adult
Who may be able to join
- Sex: Male/female.
- Age: 18 - 45 years.
- Volunteer with BMI of 18-27 kg/m2 with minimum of 50 kg weight.
- With minimum blood pressure of 110/75 mmHg.
- Healthy and willing to participate in the study.
- Signed Written Informed Consent for Screening and study.
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- Medical case history, physical examination, vital signs, laboratory tests and ECG without significant deviations.
- Negative drug of abuse screening test.
- Non-smokers or smoking less than 10 cigarettes a day and willing to break smoking in the course of the study.
- No history of medication for at least 2 weeks prior to study drug administration until study Period II completion.
Who cannot join
- Clinically relevant abnormal physical findings at the screening examination, which would interfere with the objectives of the study.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Abnormal ECG.
- Habituation of tobacco necessitating uninterrupted tobacco consumption.
- Addiction to alcohol or history of any drug abuse.
- History of kidney or liver dysfunction.
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- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- Administration/ Intake of any prescription or OTC medication for two weeks before the study.
- Patients suffering from any chronic illness such as arthritis, asthma etc.
- HIV, HCV, HBsAg positive volunteers.
- Opioids and cannabis positive volunteers based on urine test.
- Subjects suffering from any psychiatric (acute or chronic) illness.
- Administration of any investigational drug in the period 0 to 3 months before entry to the study.
- Intake of barbiturates or any enzyme-inducing drug in last three months.
- History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
- History of any bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- Serious adverse reaction or hypersensitivity to study drug or any of the excipients.
- Inability to communicate or co-operate with the investigator due to language problem, poor mental development or impaired cerebral function.
- Pregnant and nursing mother.
- Female not practicing barrier contraceptives.
- Contraindications to active or inactive ingredients of the formulation.
- Volunteers leaving to go on a holiday.
- Imminent reassignment of job location.
- Inadequate motivation.
- Can not come for the follow-up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
CEDRA Clinical Research, LLC
San Antonio, Texas, 78217
About this study
Official title: An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets [Torrent Pharmaceuticals Limited,India] Compared to a 10 mg Dose of Norvasc®, [Pfizer, USA] in 18 Fed, Healthy Adult Subjects
- Objective:
- The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions.
- Study Design:
- This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.
- Conditions
- Healthy
- Being tested
- Amlodipine Besylate, Norvasc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine BesylateDrug
10 mg tablets (Torrent Pharmaceuticals, India)
NorvascDrug
10 mg dose (Pfizer, USA)
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 posted3 Jul 2009 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932880
- Sponsor's protocol ID
- 20-061-SA
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 16 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Way Crossover, Single Dose Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets [Torrent Pharmaceuticals Limited,India] Compared to a 10 mg Dose of Norvasc®, [Pfizer, USA] in 18 Fed, Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00932880
- Acronym / sponsor ID
- 20-061-SA
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 3 Jul 2009 (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.
- Objective:
- The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions.
- Study Design:
- This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Sex: Male/female.
- Age: 18 - 45 years.
- Volunteer with BMI of 18-27 kg/m2 with minimum of 50 kg weight.
- With minimum blood pressure of 110/75 mmHg.
- Healthy and willing to participate in the study.
Key exclusion criteria (26 listed)
- Clinically relevant abnormal physical findings at the screening examination, which would interfere with the objectives of the study.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Abnormal ECG.
- Habituation of tobacco necessitating uninterrupted tobacco consumption.
- Addiction to alcohol or history of any drug abuse.
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 Besylate10 mg tablets (Torrent Pharmaceuticals, India) | Drug | – |
| Norvasc10 mg dose (Pfizer, USA) | Drug | – |
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 16 Jul 2009.
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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 Phase 1 study testing Amlodipine Besylate and Norvasc in people with Healthy, run by Torrent Pharmaceuticals 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 10 inclusion and 26 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 16 Jul 2009. 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.
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. 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 16 Jul 2009; AzTrials last refreshed its copy on 31 Oct 2026.