HealthyPhase 1NCT00932763
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 22 Fasted, 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 assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects. 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.
- Volunteers 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 refrain from smoking throughout the course of the study.
- No history of medication, prescription or OTC, 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 objective of the study.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically relevant ECG abnormalities.
- 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.
- Positive test for drugs of abuse screen.
- Subjects suffering from any psychiatric (acute or chronic) illness.
- Administration of any investigational drug in the period 0 to 30 days before entry into 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 anticipated blood loss for this study will exceed 1000 ml.
- 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 cooperate with the investigator due to language problem, poor mental development or impaired cerebral function.
- Pregnant and nursing mother.
- Female, unless surgically sterile or at least 2 years post-menopausal, not practicing barrier contraceptive methods.
- Contraindications to active or inactive ingredients of the formulation.
- Subject is not willing and able to remain in the study unit for the entire duration of each confinement period and return for all outpatient 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 22 Fasted, Healthy Adult Subjects
- Objective:
- The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects.
- Study Design:
- This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.
- 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
- NCT00932763
- Sponsor's protocol ID
- 20-085-SA
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 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 22 Fasted, Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00932763
- Acronym / sponsor ID
- 20-085-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 assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects.
- Study Design:
- This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.
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.
- Volunteers with minimum blood pressure of 110/75 mmHg.
- Healthy and willing to participate in the study.
Key exclusion criteria (23 listed)
- Clinically relevant abnormal physical findings at the screening examination, which would interfere with the objective of the study.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically relevant ECG abnormalities.
- 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 17 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 23 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 17 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 17 Jul 2009.