Healthy VolunteersPhase 1NCT01138826

Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

A Phase 1 study testing Amlodipine - reference and Amlodipine ODT - test in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Amlodipine - reference and Amlodipine ODT - test
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteIndia
Study dates: May 2010to Jun 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs).

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
A positive urine drug screen.

Trial locations and contacts

1 site in 1 country.

India1 site

Pfizer Investigational Site
Hydrabad, Andhra Pradesh, 500 050

Other trials in India

About this study

Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions

Conditions: Healthy Volunteers
Being tested: Amlodipine - reference, Amlodipine ODT - test
Keywords: biological availability, bioavailability, amlodipine, orally disintegrating tablet, ODT, tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine - referenceDrug
10 mg tablet, single dose, with water
Amlodipine ODT - testDrug
10 mg orally disintegrating tablet (ODT), single dose, with water
Amlodipine ODT - testDrug
10 mg orally disintegrating tablet (ODT), single dose, without water

Study groups in NCT01138826
Study group	Role	What they receive
treatment A - reference w/ water	Active comparator	Not described Receives: Drug: Amlodipine - reference
Treatment B - ODT (test) w/ water	Experimental	Not described Receives: Drug: Amlodipine ODT - test
Treatment C - ODT (test) w/o water	Experimental	Not described Receives: Drug: Amlodipine ODT - test

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Secondary outcomes (2)

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jun 2010

First posted7 Jun 2010 (estimated)
Study startMay 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01138826
Sponsor's protocol ID: A0531095
Other IDs: 051-10
Status last verified: Jan 2021
First submitted: 8 Mar 2010
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions
ClinicalTrials.gov ID: NCT01138826
Acronym / sponsor ID: A0531095
Conditions: Healthy Volunteers
Keywords: biological availability, bioavailability, amlodipine, orally disintegrating tablet, ODT, tablets
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Collaborators: Aurobindo Pharma Ltd, Trident Life Sciences Ltd.
Study start: May 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 7 Jun 2010 (estimated)
Results: Posted 20 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
treatment A - reference w/ water	Active comparator	Drug: Amlodipine - reference
Treatment B - ODT (test) w/ water	Experimental	Drug: Amlodipine ODT - test
Treatment C - ODT (test) w/o water	Experimental	Drug: Amlodipine ODT - test

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs).

Key exclusion criteria (2 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
A positive urine drug screen.

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 - reference10 mg tablet, single dose, with water	Drug	treatment A - reference w/ water
Amlodipine ODT - test10 mg orally disintegrating tablet (ODT), single dose, with water	Drug	Treatment B - ODT (test) w/ water
Amlodipine ODT - test10 mg orally disintegrating tablet (ODT), single dose, without water	Drug	Treatment C - ODT (test) w/o water

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

2 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose
Plasma Decay Half-Life (t1/2)
Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Results and safety

Results posted to the registry on 20 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water	3	3
Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT	3	3
Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet	3	3
Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water	3	3
Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT	3	3
Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet	3	3

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Full Range). Unit: hr*ng/mL

Measure	Amlodipine 10mg Tablet With Water (Reference Product A) n = 17	Amlodipine 10 mg ODT With Water (Test Product B) n = 15	Amlodipine 10 mg ODT Without Water (Test Product C) n = 16
Value	307.225 (61.736 to 468.617)	324.324 (48.000 to 554.452)	330.411 (54.526 to 687.254)

Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT With Water (Test Product B): Adjusted ratio of geometric means: 105.57 (90% CI 98.09 to 113.61)
Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 107.55 (90% CI 99.98 to 115.69)
Amlodipine 10 mg ODT With Water (Test Product B) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 101.88 (90% CI 94.70 to 109.60)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: AUC From Time Zero to Last Quantifiable Concentration (AUClast)

Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Full Range). Unit: hr*ng/mL

Measure	Amlodipine 10mg Tablet With Water (Reference Product A) n = 17	Amlodipine 10 mg ODT With Water (Test Product B) n = 15	Amlodipine 10 mg ODT Without Water (Test Product C) n = 16
Value	275.302 (60.422 to 439.855)	285.974 (46.480 to 439.395)	287.035 (52.378 to 482.589)

Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT With Water (Test Product B): Adjusted ratio of geometric means: 103.88 (90% CI 97.27 to 110.94)
Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 104.26 (90% CI 97.67 to 111.30)
Amlodipine 10 mg ODT With Water (Test Product B) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 100.37 (90% CI 94.02 to 107.15)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Full Range). Unit: ng/mL

Measure	Amlodipine 10mg Tablet With Water (Reference Product A) n = 17	Amlodipine 10 mg ODT With Water (Test Product B) n = 15	Amlodipine 10 mg ODT Without Water (Test Product C) n = 16
Value	5.201 (1.880 to 9.350)	5.117 (1.410 to 7.400)	4.952 (1.500 to 7.020)

Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT With Water (Test Product B): Adjusted ratio of geometric means: 98.39 (90% CI 91.05 to 106.33)
Amlodipine 10mg Tablet With Water (Reference Product A) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 95.22 (90% CI 88.16 to 102.84)
Amlodipine 10 mg ODT With Water (Test Product B) vs Amlodipine 10 mg ODT Without Water (Test Product C): Adjusted ratio of geometric means: 96.77 (90% CI 89.58 to 104.54)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine 10mg Tablet With Water (Reference Product A)	0 of 18 (0%)	0 of 18 (0%)	Not reported
Amlodipine 10 mg ODT With Water (Test Product B)	0 of 18 (0%)	0 of 18 (0%)	Not reported
Amlodipine 10 mg ODT Without Water (Test Product C)	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

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 - reference and Amlodipine ODT - test in people with Healthy Volunteers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in India.

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 2 inclusion and 2 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 28 Jan 2021. 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 India. 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?

Yes. Results are posted in the registry (first posted 20 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] (time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01138826.

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 28 Jan 2021.