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A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POS formulation #1 | Experimental |
| |
| POS formulation #2 | Experimental |
| |
| commercial tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug | powder for oral suspension 4 mg/mL single dose (8 mL) |
| |
| 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 - ∞). | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose |
| Maximum Observed Plasma Concentration (Cmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs 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. |
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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 | Singapore | 188770 | Singapore |
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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 | Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2 | Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| FG001 | Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1 | Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| FG002 | Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2 | Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| FG003 | Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet | Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| FG004 | Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1 | Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| FG005 | Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet | Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| ||||||||||||||||||
| Washout Period (At Least 2 Days) |
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| Second Intervention Period |
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| Washout Period (At Least 2 Days) |
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| Third Intervention Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first. |
| 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 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 participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) 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 | Methylprednisolone 32 mg Tablet | Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | 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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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| methylprednisolone |
| Drug |
powder for oral suspension 4 mg/mL singe dose (8 ml) |
|
| methylprednisolone | Drug | tablet 32 mg single dose |
|
| 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Methylprednisolone 32 mg Micronized API |
Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods. |
| OG002 | Methylprednisolone 32 mg Sieve Cut API | Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods. |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose |
|
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Median | Full Range | hr | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose |
|
|
|
| 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 participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Mean | Standard Deviation | hr | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose |
|
|
|
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Methylprednisolone 32 mg Micronized API | Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods. | 0 | 22 | 0 | 22 |
| EG002 | Methylprednisolone 32 mg Sieve Cut API | Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods. | 0 | 23 | 1 | 23 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 13.1 | 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.
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|
Natural log transformed Cmax of methylprednisolone was analyzed using 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. |
| Ratio of adjusted geometric means |
| 83.89 |
| 2-Sided |
| 90 |
| 78.06 |
| 90.17 |
| No |
| Superiority or Other |