Eletriptan Pharmacokinetics In Korean Males
Study Details
Study Description
Brief Summary
The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment A 1 X 20 mg eletriptan |
Drug: Eletriptan commercial tablet
20 mg tablet, single dose
|
Experimental: Treatment B 1 X 40 mg eletriptan |
Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 1 X 40 mg
|
Experimental: Treatment C 2 X 40 mg eletriptan |
Drug: Eletriptan commercial tablet
40 mg tablet, single dose of 2 X 40 mg
|
Experimental: Treatment D 1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose |
Drug: Eletriptan commercial tablet
40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first
|
Outcome Measures
Primary Outcome Measures
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [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 (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) [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)]
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) [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)]
Secondary Outcome Measures
- 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) [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 is the time measured for the plasma concentration to decrease by one half.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
healthy male subjects, 18-55 years old
-
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
-
provide informed consent
Exclusion Criteria:
-
blood pressure >140/90 mm Hg
-
any condition possibly affecting drug absorption
-
positive urine drug screen
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1601126
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose | Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose | Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg | Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg |
---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | 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. |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Period Title: First Intervention Period | ||||
STARTED | 4 | 4 | 4 | 4 |
COMPLETED | 4 | 4 | 4 | 4 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Entire Study Population |
---|---|
Arm/Group Description | 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). |
Overall Participants | 16 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
24.8
(2.9)
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
16
100%
|
Outcome Measures
Title | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
---|---|
Description | 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-∞). |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|---|---|
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
Measure Participants | 16 | 16 | 16 | 16 |
Geometric Mean (Full Range) [ng* hr/mL] |
291.3
|
575.6
|
1282.0
|
1278.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet |
---|---|---|
Comments | Natural log transformed, dose-normalized AUC[0- ∞] 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 98.70 | |
Confidence Interval |
(2-Sided) 90% 92.17 to 105.70 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|
Comments | Natural log transformed, dose-normalized AUC[0- ∞] 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 109.48 | |
Confidence Interval |
(2-Sided) 90% 102.23 to 117.24 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet |
---|---|---|
Comments | Natural log transformed, dose-normalized AUC[0- ∞] 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 109.93 | |
Confidence Interval |
(2-Sided) 90% 102.65 to 117.72 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | AUC From Time Zero to Last Quantifiable Concentration (AUClast) |
---|---|
Description | Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast). |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|---|---|
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
Measure Participants | 16 | 16 | 16 | 16 |
Geometric Mean (Full Range) [ng*hr/mL] |
281.2
|
558.7
|
1243.0
|
1244.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted geometric means ratio |
Estimated Value | 99.41 | |
Confidence Interval |
(2-Sided) 90% 92.97 to 106.31 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 110.52 | |
Confidence Interval |
(2-Sided) 90% 103.36 to 118.18 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 110.44 | |
Confidence Interval |
(2-Sided) 90% 103.28 to 118.09 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Maximum Observed Plasma Concentration (Cmax) |
---|---|
Description | |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|---|---|
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
Measure Participants | 16 | 16 | 16 | 16 |
Geometric Mean (Full Range) [ng/mL] |
46.50
|
94.72
|
200.10
|
183.60
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted geometric means ratio |
Estimated Value | 101.81 | |
Confidence Interval |
(2-Sided) 90% 85.97 to 120.58 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 98.57 | |
Confidence Interval |
(2-Sided) 90% 83.23 to 116.73 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Eletriptan 20 mg Tablet, Eletriptan 80 mg Tablet |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Adjusted ratio of geometric means |
Estimated Value | 107.44 | |
Confidence Interval |
(2-Sided) 90% 90.72 to 127.25 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
---|---|
Description | |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|---|---|
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
Measure Participants | 16 | 16 | 16 | 16 |
Median (Full Range) [Hr] |
0.750
|
0.750
|
0.750
|
5.000
|
Title | Plasma Decay Half Life (t1/2) |
---|---|
Description | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose |
---|---|---|---|---|
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). |
Measure Participants | 16 | 16 | 16 | 16 |
Mean (Standard Deviation) [Hr] |
4.924
(0.685)
|
4.630
(0.447)
|
4.576
(0.531)
|
4.753
(0.623)
|
Adverse Events
Time Frame | ||||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||||
Arm/Group Title | Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg 2 Hrs Apart Repeated Dose | ||||
Arm/Group Description | Single oral dose of eletriptan 20 mg tablet (Treatment A). | Single oral dose of eletriptan 40 mg tablet (Treatment B). | Single oral dose of two eletriptan 40 mg tablets (Treatment C). | Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D). | ||||
All Cause Mortality |
||||||||
Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg 2 Hrs Apart Repeated Dose | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg 2 Hrs Apart Repeated Dose | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Eletriptan 20 mg Tablet | Eletriptan 40 mg Tablet | Eletriptan 80 mg Tablet | Eletriptan 40 mg 2 Hrs Apart Repeated Dose | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/16 (6.3%) | 1/16 (6.3%) | 4/16 (25%) | 3/16 (18.8%) | ||||
Gastrointestinal disorders | ||||||||
Nausea | 1/16 (6.3%) | 1/16 (6.3%) | 1/16 (6.3%) | 0/16 (0%) | ||||
Oral mucosa erosion | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) | 1/16 (6.3%) | ||||
General disorders | ||||||||
Chest discomfort | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) | 1/16 (6.3%) | ||||
Fatigue | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) | 0/16 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Musculoskeletal stiffness | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) | ||||
Nervous system disorders | ||||||||
Headache | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) | 1/16 (6.3%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Oropharyngeal discomfort | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) | 1/16 (6.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A1601126