HealthyPhase 1NCT01004614

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

A Phase 1 study testing Amlodipine in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.

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 conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent. Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteJapan
Study dates: Nov 2009to Dec 2009
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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy;
Body Mass Index (BMI) of 18 to 28 kg/m2;
total body weight within the range of 50 to 100 kg

Who cannot join

History of regular alcohol consumption exceeding 14 drinks/week
Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Investigational Site
Minato-ku, Tokyo

Other trials in Japan

About this study

Official title: An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

Conditions: Healthy
Being tested: Amlodipine

What participants receive

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

AmlodipineDrug
3rd OD 5 mg tablet single oral dose administered with water
AmlodipineDrug
2nd OD 5 mg tablet single oral dose administered with water
AmlodipineDrug
3rd OD 5 mg tablet single oral dose administered without water
AmlodipineDrug
2nd OD 5 mg tablet single oral dose administered without water

Study groups in NCT01004614
Study group	Role	What they receive
Cohort 1	Experimental	24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water. Receives: Drug: Amlodipine
Cohort 2	Active comparator	24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water Receives: Drug: Amlodipine

What is being measured

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

Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
Area under the concentration-time curve from zero time until the last sampling time
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Secondary outcomes (5)

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.
AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration.
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Apparent Terminal Elimination Phase Rate Constant (Kel)
Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Apparent Terminal Elimination Half-Life (T-half)
Terminal phase half-life calculated as ln(2) / kel
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Mean Residence Time (MRT)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Timeline

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

Nov 2009Dec 2009

First posted30 Oct 2009 (estimated)
Study startNov 2009
Primary completionDec 2009
Study completionDec 2009

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 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01004614
Sponsor's protocol ID: A0531088
Status last verified: Jan 2021
First submitted: 29 Oct 2009
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?

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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: An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
ClinicalTrials.gov ID: NCT01004614
Acronym / sponsor ID: A0531088
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 30 Oct 2009 (estimated)
Results: Posted 4 Jan 2012

Clinical summary

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

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: Amlodipine24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.
Cohort 2	Active comparator	Drug: Amlodipine24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy;
Body Mass Index (BMI) of 18 to 28 kg/m2;
total body weight within the range of 50 to 100 kg

Key exclusion criteria (2 listed)

History of regular alcohol consumption exceeding 14 drinks/week
Use of tobacco- or nicotine-containing products in excess of the equivalent of 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
Amlodipine3rd OD 5 mg tablet single oral dose administered with water	Drug	Cohort 1
Amlodipine2nd OD 5 mg tablet single oral dose administered with water	Drug	Cohort 1
Amlodipine3rd OD 5 mg tablet single oral dose administered without water	Drug	Cohort 2
Amlodipine2nd OD 5 mg tablet single oral dose administered without water	Drug	Cohort 2

Primary outcome

Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the concentration-time curve from zero time until the last sampling time
Maximum Observed Plasma Concentration (Cmax)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

5 secondary outcomes

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Apparent Terminal Elimination Phase Rate Constant (Kel)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Apparent Terminal Elimination Half-Life (T-half)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Mean Residence Time (MRT)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Results and safety

Results posted to the registry on 4 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3rd OD Tablet With Water, Then 2nd OD Tablet With Water	12	12
2nd OD Tablet With Water, Then 3rd OD Tablet With Water	12	12
3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water	12	12
2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water	12	12

Primary outcome: Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)

Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Cohort I: 3rd OD Tablet (Test) With Water n = 23	Cohort I: 2nd OD Tablet (Reference) With Water n = 23	Cohort II: 3rd OD Tablet (Test) Without Water n = 24	Cohort II: 2nd OD Tablet (Reference) Without Water n = 24
Value	126.36 (33.16)	129.48 (39.93)	122.33 (32.59)	119.75 (28.23)

Cohort I: 3rd OD Tablet (Test) With Water vs Cohort I: 2nd OD Tablet (Reference) With Water vs Cohort II: 3rd OD Tablet (Test) Without Water vs Cohort II: 2nd OD Tablet (Reference) Without Water: ratios of adjusted geometric mean: 98.61 (90% CI 93.09 to 104.46)
Cohort I: 3rd OD Tablet (Test) With Water vs Cohort I: 2nd OD Tablet (Reference) With Water vs Cohort II: 3rd OD Tablet (Test) Without Water vs Cohort II: 2nd OD Tablet (Reference) Without Water: ratios of adjusted geometric mean: 101.29 (90% CI 97.28 to 105.45)

Population analysed: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort I: 3rd OD Tablet (Test) With Water n = 23	Cohort I: 2nd OD Tablet (Reference) With Water n = 23	Cohort II: 3rd OD Tablet (Test) Without Water n = 24	Cohort II: 2nd OD Tablet (Reference) Without Water n = 24
Value	2.70 (0.513)	2.74 (0.650)	2.48 (0.470)	2.45 (0.409)

Cohort I: 3rd OD Tablet (Test) With Water vs Cohort I: 2nd OD Tablet (Reference) With Water vs Cohort II: 3rd OD Tablet (Test) Without Water vs Cohort II: 2nd OD Tablet (Reference) Without Water: ratios of adjusted geometric mean: 99.30 (90% CI 92.28 to 106.28)
Cohort I: 3rd OD Tablet (Test) With Water vs Cohort I: 2nd OD Tablet (Reference) With Water vs Cohort II: 3rd OD Tablet (Test) Without Water vs Cohort II: 2nd OD Tablet (Reference) Without Water: ratios of adjusted geometric mean: 100.84 (90% CI 95.93 to 106.00)

Population analysed: The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.

5 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
Cohort I: 3rd OD Tablet (Test) With Water	0 of 23 (0%)	7 of 23 (30.4%)	Not reported
Cohort I: 2nd OD Tablet (Reference) With Water	0 of 24 (0%)	6 of 24 (25%)	Not reported
Cohort II: 3rd OD Tablet (Test) Without Water	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
Cohort II: 2nd OD Tablet (Reference) Without Water	0 of 24 (0%)	3 of 24 (12.5%)	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 in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.

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 3 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 Japan. 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 4 Jan 2012). 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 Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt) (time frame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose). 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?

On the ClinicalTrials.gov record for NCT01004614.

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.