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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | 3rd OD 5 mg tablet single oral dose administered with water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Minato-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This study consisted of 2 cohorts (I and II). The design of each cohort was an open-label, randomized, 2-periods, crossover, single-dose study in healthy adult male subjects. A washout period of at least 14 days was taken between each administration in Periods 1 and 2.
Participants were screened at one center in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3rd OD Tablet With Water, Then 2nd OD Tablet With Water | One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods. |
| FG001 | 2nd OD Tablet With Water, Then 3rd OD Tablet With Water | One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods. |
| FG002 | 3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water | One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods. |
| FG003 | 2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water | One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 3rd OD Tablet With Water, Then 2nd OD Tablet With Water | One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | ng*h/mL | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort I: 3rd OD Tablet (Test) With Water | Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Amlodipine |
| Drug |
2nd OD 5 mg tablet single oral dose administered with water |
|
| Amlodipine | Drug | 3rd OD 5 mg tablet single oral dose administered without water |
|
| Amlodipine | Drug | 2nd OD 5 mg tablet single oral dose administered without water |
|
| 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. | 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 | 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. | 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) | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG001 |
| 2nd OD Tablet With Water, Then 3rd OD Tablet With Water |
One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods. |
| BG002 | 3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water | One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods. |
| BG003 | 2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water | One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Cohort II: 3rd OD Tablet (Test) Without Water | Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose |
| OG003 | Cohort II: 2nd OD Tablet (Reference) Without Water | Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | ng/mL | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
|
| Secondary | 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. | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | ng*h/mL | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
| Secondary | 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. | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | L/h | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
| Secondary | Apparent Terminal Elimination Half-Life (T-half) | Terminal phase half-life calculated as ln(2) / kel | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | hour | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
| Secondary | 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. | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Mean | Standard Deviation | hour | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | The PK parameter analysis set was defined as all subjects randomized and treated who completed the study. | Posted | Median | Full Range | hour | prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose |
|
|
|
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Cohort I: 2nd OD Tablet (Reference) With Water | Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose | 0 | 24 | 6 | 24 |
| EG002 | Cohort II: 3rd OD Tablet (Test) Without Water | Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose | 0 | 24 | 2 | 24 |
| EG003 | Cohort II: 2nd OD Tablet (Reference) Without Water | Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose | 0 | 24 | 3 | 24 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pharingitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Oropharyngeal disconfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Non-Inferiority or Equivalence (legacy) |
Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%). |
| Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU). | Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. | ratios of adjusted geometric mean | 100.84 | 2-Sided | 90 | 95.93 | 106.00 | Non-Inferiority or Equivalence (legacy) | Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%). |
| AUCinf |
|