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To establish bioequivalence at steady state of:
1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status
To investigate dose proportionality of pharmacokinetics parameters for:
1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pramipexole extended release | Experimental | 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) |
|
| pramipexole immediate release | Active Comparator | 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramipexole extended release | Drug | 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects) | AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state | 27 days |
| Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis) | AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state | 27 days |
| Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects) | Cmax = maximum observed concentration of the analyte in plasma at steady state | 27 days |
| Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis) | Cmax,ss = maximum observed concentration of the analyte in plasma at steady state | 27 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects) | tmax = time of maximum observed plasma concentration | 27 days |
| Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis) |
Not provided
Inclusion criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
Age older than or equal 18 and Age younger than or equal 40 years
Body Mass Index larger than or equal 19 and Body Mass Index less than or equal 24kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.
Exclusion criteria:
Any finding of the medical examination (including Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results of the trial up to 7 days before the start of drug administration in the study or during the study period
Participation in another trial with an investigational drug within one months prior to administration or during the trial
Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 40 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency virus (HIV) test
Exclusion criteria specific for this study:
Hypersensitivity to pramipexole or other dopamine agonists
Supine blood pressure at screening of systolic<100 mmHg and diastolic < 60 mmHg, or symptomatic orthostatic hypotension (i. .e. clinical symptoms of orthostatic hypotension associated with a decline >=20 mmHg in systolic BP and a decline >=10 mmHg in diastolic BP, at one minute after standing compared to the previous supine systolic and diastolic BP obtained after 5 minutes of quiet rest)
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 248.665.86002 Boehringer Ingelheim Investigational Site | Beijing | China |
24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented in the milestone are by overall treatment, A, B, C or D.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.375 mg q.d.Extended Release (ER) | 0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole |
| FG001 | 0.125 mg t.i.d. Immediate Release (IR) | 0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole |
| FG002 | 1.5 mg q.d. ER | 1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole |
| FG003 | 0.5 mg t.i.d. IR | 0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | 24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment. |
| 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 of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects) | AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state | PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 27 days |
|
27 days
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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 | 0.375 mg q.d.ER | 0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| pramipexole extended release | Drug | 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) |
|
| pramipexole immediate release | Drug | 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) |
|
| pramipexole immediate release | Drug | 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) |
|
tmax = time of maximum observed plasma concentration |
| 27 days |
| Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects) | PTF = Peak-to-trough fluctuation is measured as a percent | 27 days |
| Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis) | PTF = Peak-to-trough fluctuation is measured as a percent | 27 days |
| Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects) | Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose | 27 days |
| Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis) | Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose | 27 days |
| Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects) | Cavg = Average concentration of the analyte in plasma at steady state | 27 days |
| Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis) | Cavg = Average concentration of the analyte in plasma at steady state | 27 days |
| Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects) | t1/2,ss - Apparent plasma terminal elimination half-life at steady state | 27 days |
| Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis) | t1/2,ss - Apparent plasma terminal elimination half-life at steady state | 27 days |
| Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects) | Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state | 27 days |
| Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis) | Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state | 27 days |
| The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects) | CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration | 27 days |
| The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis) | CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration | 27 days |
| Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects) | Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration | 27 days |
| Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis) | Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration | 27 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole |
| OG002 | 1.5 mg q.d. ER | 1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole |
| OG003 | 0.5 mg t.i.d. IR | 0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole |
|
|
|
| Primary | Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis) | AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state | PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 27 days |
|
|
|
|
| Primary | Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects) | Cmax = maximum observed concentration of the analyte in plasma at steady state | PK population - Subjects with values for Cmax,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
|
| Primary | Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis) | Cmax,ss = maximum observed concentration of the analyte in plasma at steady state | PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
|
| Secondary | Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects) | tmax = time of maximum observed plasma concentration | PK population - Subjects with values for tmax | Posted | Median | Full Range | hours | 27 days |
|
|
|
| Secondary | Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis) | tmax = time of maximum observed plasma concentration | PK population excluding subjects with reported emesis - Subjects with values for t_max excluding subjects with reported emesis | Posted | Median | Full Range | hours | 27 days |
|
|
|
| Secondary | Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects) | PTF = Peak-to-trough fluctuation is measured as a percent | PK population - Subjects with values for PTF | Posted | Geometric Mean | Geometric Coefficient of Variation | percent | 27 days |
|
|
|
| Secondary | Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis) | PTF = Peak-to-trough fluctuation is measured as a percent | PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | percent | 27 days |
|
|
|
| Secondary | Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects) | Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose | PK population - Subjects with values for Cpre,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis) | Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose | PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects) | Cavg = Average concentration of the analyte in plasma at steady state | PK Population - Subjects with values for Cavg | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis) | Cavg = Average concentration of the analyte in plasma at steady state | PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects) | t1/2,ss - Apparent plasma terminal elimination half-life at steady state | PK Population - Subjects with values for t1/2,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 27 days |
|
|
|
| Secondary | Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis) | t1/2,ss - Apparent plasma terminal elimination half-life at steady state | PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 27 days |
|
|
|
| Secondary | Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects) | Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state | PK Population - Subjects with values for Cmin,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis) | Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state | PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 27 days |
|
|
|
| Secondary | The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects) | CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration | PK Population - Subjects with values for CL/F,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 27 days |
|
|
|
| Secondary | The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis) | CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration | PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 27 days |
|
|
|
| Secondary | Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects) | Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration | PK Population - Subjects with values for Vz/F,ss | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 27 days |
|
|
|
| Secondary | Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis) | Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration | PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 27 days |
|
|
|
| 0 |
| 24 |
| 14 |
| 24 |
| EG001 | 0.75 mg q.d. ER Up-titration | 0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole | 0 | 24 | 9 | 24 |
| EG002 | 1.5 mg q.d. ER | 1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole | 0 | 24 | 12 | 24 |
| EG003 | 0.75 mg q.d. ER Down-titration | 0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole | 0 | 24 | 6 | 24 |
| EG004 | 0.375 mg q.d.ER Down-titration | 0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole | 0 | 24 | 0 | 24 |
| EG005 | 0.125 mg t.i.d. IR | 0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole | 0 | 24 | 8 | 24 |
| EG006 | 0.5 mg t.i.d. IR | 0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole | 0 | 24 | 14 | 24 |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| ANOVA |
| Ratio of geometric least squares means |
| 89.37 |
| 90 |
| 81.16 |
| 98.42 |
| No |
| Superiority or Other |
| ANOVA |
| Ratio of geometric least squares means |
| 91.97 |
| 90 |
| 60.07 |
| 140.25 |
| No |
| Superiority or Other |
| ANOVA |
| Ratio of geometric least squares means |
| 95.05 |
| 90 |
| 84.88 |
| 106.43 |
| No |
| Superiority or Other |