Trial Outcomes & Findings for A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form (NCT NCT01267201)
NCT ID: NCT01267201
Last Updated: 2012-06-28
Results Overview
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 - ∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
Results posted on
2012-06-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
First Intervention Period
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
First Intervention Period
COMPLETED
|
3
|
4
|
4
|
4
|
4
|
4
|
|
First Intervention Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (At Least 2 Days)
STARTED
|
3
|
3
|
4
|
4
|
4
|
4
|
|
Washout Period (At Least 2 Days)
COMPLETED
|
3
|
3
|
4
|
4
|
4
|
4
|
|
Washout Period (At Least 2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period
STARTED
|
3
|
4
|
4
|
4
|
4
|
4
|
|
Second Intervention Period
COMPLETED
|
3
|
3
|
4
|
4
|
4
|
4
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Third Intervention Period
STARTED
|
3
|
3
|
4
|
4
|
4
|
4
|
|
Third Intervention Period
COMPLETED
|
3
|
3
|
4
|
4
|
4
|
4
|
|
Third Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
First Intervention Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
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.
|
|---|---|
|
Age Continuous
|
32.5 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dosePopulation: 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.
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 - ∞).
Outcome measures
| Measure |
Methylprednisolone 32 mg Tablet
n=24 Participants
Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
|
Methylprednisolone 32 mg Micronized API
n=22 Participants
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.
|
Methylprednisolone 32 mg Sieve Cut API
n=23 Participants
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.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
1286.00 ng*hr/mL
Standard Deviation 385.27
|
1204.00 ng*hr/mL
Standard Deviation 394.65
|
1180.00 ng*hr/mL
Standard Deviation 355.26
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dosePopulation: 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.
Outcome measures
| Measure |
Methylprednisolone 32 mg Tablet
n=24 Participants
Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
|
Methylprednisolone 32 mg Micronized API
n=22 Participants
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.
|
Methylprednisolone 32 mg Sieve Cut API
n=23 Participants
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.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
289.00 ng/mL
Standard Deviation 60.42
|
279.10 ng/mL
Standard Deviation 82.91
|
246.20 ng/mL
Standard Deviation 66.05
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dosePopulation: 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.
Outcome measures
| Measure |
Methylprednisolone 32 mg Tablet
n=24 Participants
Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
|
Methylprednisolone 32 mg Micronized API
n=22 Participants
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.
|
Methylprednisolone 32 mg Sieve Cut API
n=23 Participants
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.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
2.00 hr
Interval 1.0 to 4.0
|
1.00 hr
Interval 0.5 to 4.0
|
2.00 hr
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dosePopulation: 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Methylprednisolone 32 mg Tablet
n=24 Participants
Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
|
Methylprednisolone 32 mg Micronized API
n=22 Participants
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.
|
Methylprednisolone 32 mg Sieve Cut API
n=23 Participants
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.
|
|---|---|---|---|
|
Plasma Decay Half-life (t1/2)
|
2.43 hr
Standard Deviation 0.39
|
2.42 hr
Standard Deviation 0.37
|
2.45 hr
Standard Deviation 0.35
|
Adverse Events
Methylprednisolone 32 mg Tablet
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Methylprednisolone 32 mg Micronized API
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylprednisolone 32 mg Sieve Cut API
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylprednisolone 32 mg Tablet
n=24 participants at risk
Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
|
Methylprednisolone 32 mg Micronized API
n=22 participants at risk
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.
|
Methylprednisolone 32 mg Sieve Cut API
n=23 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.2%
1/24
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.
|
0.00%
0/22
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.
|
0.00%
0/23
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24
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.
|
0.00%
0/22
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.
|
0.00%
0/23
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.
|
|
Nervous system disorders
Headache
|
12.5%
3/24
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.
|
0.00%
0/22
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.
|
0.00%
0/23
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.
|
|
Nervous system disorders
Paraesthesia
|
4.2%
1/24
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.
|
0.00%
0/22
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.
|
0.00%
0/23
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.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/24
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.
|
0.00%
0/22
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.
|
4.3%
1/23
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER