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The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 1 X 20 mg eletriptan |
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| Treatment B | Experimental | 1 X 40 mg eletriptan |
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| Treatment C | Experimental | 2 X 40 mg eletriptan |
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| Treatment D | Experimental | 1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eletriptan commercial tablet | Drug | 20 mg tablet, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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-∞). | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D) |
| 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). | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
| Maximum Observed Plasma Concentration (Cmax) | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) | |
| Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
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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 | Seoul | 110-744 | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose | Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period. |
| FG001 | Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose | Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period. |
| FG002 | Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg | Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period. |
| FG003 | Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg | Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Washout Period I (46hrs) |
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| Second Intervention Period |
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| Washout Period 2 (46 Hrs) |
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| Third Intervention Period |
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| Washout Period 3 (46 Hrs) |
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| Fourth Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total). |
| Units | Counts |
|---|---|
| Participants |
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| 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 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-∞). | 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. | Posted | Geometric Mean | Full Range | ng* hr/mL | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D) |
|
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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 | Eletriptan 20 mg Tablet | Single oral dose of eletriptan 20 mg tablet (Treatment A). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | medDRA v13.0 | Non-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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| Eletriptan commercial tablet |
| Drug |
40 mg tablet, single dose of 1 X 40 mg |
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| Eletriptan commercial tablet | Drug | 40 mg tablet, single dose of 2 X 40 mg |
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| Eletriptan commercial tablet | Drug | 40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first |
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| Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Eletriptan 40 mg Tablet |
Single oral dose of eletriptan 40 mg tablet (Treatment B). |
| OG002 | Eletriptan 80 mg Tablet | Single oral dose of two eletriptan 40 mg tablets (Treatment C). |
| OG003 | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
|
|
|
| Primary | 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). | 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. | Posted | Geometric Mean | Full Range | ng*hr/mL | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
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| Primary | Maximum Observed Plasma Concentration (Cmax) | 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. | Posted | Geometric Mean | Full Range | ng/mL | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
|
|
|
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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. | Posted | Median | Full Range | Hr | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
|
|
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| Secondary | Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 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. | Posted | Mean | Standard Deviation | Hr | Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D) |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Eletriptan 40 mg Tablet | Single oral dose of eletriptan 40 mg tablet (Treatment B). | 0 | 16 | 1 | 16 |
| EG002 | Eletriptan 80 mg Tablet | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | 0 | 16 | 4 | 16 |
| EG003 | Eletriptan 40 mg 2 Hrs Apart Repeated Dose | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). | 0 | 16 | 3 | 16 |
| Oral mucosa erosion | Gastrointestinal disorders | medDRA v13.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | medDRA v13.0 | Non-systematic Assessment |
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| Fatigue | General disorders | medDRA v13.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | medDRA v13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | medDRA v13.0 | Non-systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | medDRA v13.0 | Non-systematic Assessment |
|
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.
| Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. | Adjusted ratio of geometric means | 110.52 | 2-Sided | 90 | 103.36 | 118.18 | Superiority or Other (legacy) |
| Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. | Adjusted ratio of geometric means | 110.44 | 2-Sided | 90 | 103.28 | 118.09 | Superiority or Other (legacy) |
| Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. | Adjusted ratio of geometric means | 98.57 | 2-Sided | 90 | 83.23 | 116.73 | Superiority or Other (legacy) |
| Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. | Adjusted ratio of geometric means | 107.44 | 2-Sided | 90 | 90.72 | 127.25 | Superiority or Other (legacy) |