Healthy
Conditions
Brief summary
The main objective of Trial Parts 1 and 2 is to investigate the relative bioavailability of two tablet strengths (low dose and high dose) of the intended Commercial Formulation of BI 730357 (Test, T) versus with the corresponding tablet strengths of Trial Formulation 1 (Reference, R). The main objective of Trial Part 3 is to investigate the relative bioavailability of two iCF side batches of BI 730357 with coarse milled Active pharmaceutical ingredient (API)(Test coarse milled, Tc) and unmilled API (Test unmilled, Tu), respectively, versus the final iCF batch of BI 730357 with regularly milled API (Reference, R).
Interventions
DRUGBI 730357 (Test)
tablet
DRUGBI 730357 (Reference)
tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 50 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation * Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: * Use of adequate contraception, e.g. any of the following methods plus condom: \--- implants, injectables, combined oral or vaginal contraceptives, intrauterine device * Sexually abstinent * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) * Surgically sterilised (including hysterectomy) * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion criteria
* Any finding in the medical examination (including Blood pressure (BP), PR or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Chronic or relevant acute infections * History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) * Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation) * Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered * Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) * Inability to refrain from smoking on specified trial days * Alcohol abuse (consumption of more than 12 g per day for females and 24 g per day for males) * Drug abuse or positive drug screening * Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial * Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial * Inability to comply with the dietary regimen of the trial site * A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening * A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome) * Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study * Female subjects will not be allowed to participate, if any of the following apply: \-- Positive pregnancy test, pregnancy, or plans to become pregnant within 30 days after study completion * Lactation * Male subjects with Woman of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of first administration of trial medication until 30 days after the last administration of trial medication * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration. | Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). |
| Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration. | Maximum measured concentration of BI 730357 in plasma (Cmax). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration. | Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). |
Countries
Germany
Participant flow
Recruitment details
An open-label, single dose, randomized, 2-way and 3-way crossover trial in healthy subjects compared the relative bioavailability of intended commercial formulations (iCF) of BI 730357 to BI 730357 trial formulation 1 (TF1); and compared the bioavailability of different iCF batches (coarse-milled vs. unmilled vs. regularly milled).
Pre-assignment details
Only subjects that met all the study inclusion and non of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
Participants by arm
| Arm | Count |
|---|---|
| 50 mg BI 730357 iCF (T1) / 50 mg BI 730357 TF 1 (R1) 1 tablet of 50 milligram (mg) BI 730357 intended commercial formulations (iCF) final batch was administered as a single oral dose with 240 milliliter (mL) water as test treatment 1 (T1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 tablet formulation 1 (TF1), administered as a single oral dose with 240 mL water as reference treatment 1 (R1) after an overnight fast of at least 10h. | 7 |
| 50 mg BI 730357 TF1 (R1) / 50 mg 730357 iCF (T1) 1 tablet of 50 milligram (mg) BI 730357 tablet formulation (TF1) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 1 (R1) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 50 mg BI 730357 intended commercial formulations (iCF) final batch, administered as a single oral dose with 240 mL of water at test treatment 1 (T1) after an overnight fast of at least 10h. | 7 |
| 200 mg BI 730357 iCF (T2) / 200 mg BI 730357 TF1 (R2) 2 tablets of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch were administered as a single oral dose with 240 milliliter (mL) water as test treatment 2 (T2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 tablet formulation 1 (TF1), administered as single oral dose with 240 mL water as reference treatment 2 (R2) after an overnight fast of at least 10h. | 7 |
| 200 mg BI 730357 TF1 (R2)/ 200 mg BI 730357 iCF (T2) 2 tablets of 100 milligram (mg) BI 730357 tablet formulation 1 (TF1) were administered as a single oral dose with 240 milliliter (mL) of water as reference treatment 2 (R2) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 2 tablets of 100 mg BI 730357 intended commercial formulation (iCF) final batch, administered as a single oral dose with 240 mL water as test treatment 2 (T2) after an overnight fast of at least 10h. | 7 |
| 100 mg BI 730357 Regularly Milled (R3)/ Coarse-milled (T3c)/ Unmilled (T3u) 1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) final batch regularly milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as reference treatment 3 (R3) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h. | 5 |
| 100 mg BI 730357 Coarse Milled (T3c) / Unmilled (T3u)/Regularly Milled (R3) 1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch coarse-milled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3c (T3c) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch unmilled API, administered as a single oral dose with 240 mL water as test treatment 3u (T3u) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single oral dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h. | 5 |
| 100 mg BI 730357 Unmilled (T3u) /Regularly Milled (R3)/Coarse Milled (T3c) 1 tablet of 100 milligram (mg) BI 730357 intended commercial formulation (iCF) side batch unmilled active pharmaceutical ingredient (API) was administered as a single oral dose with 240 milliliter (mL) water as test treatment 3u (T3u) after an overnight fast of at least 10 hours (h), followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF final batch regularly milled API, administered as a single dose with 240 mL water as reference treatment 3 (R3) after an overnight fast of at least 10 h, followed by a wash-out phase of at least 10 days, followed by 1 tablet of 100 mg BI 730357 iCF side batch coarse-milled API, administered as a single oral dose with 240 mL water as test treatment 3c (T3c) after an overnight fast of at least 10 h. | 5 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 50 mg BI 730357 iCF (T1) / 50 mg BI 730357 TF 1 (R1) | 50 mg BI 730357 TF1 (R1) / 50 mg 730357 iCF (T1) | 200 mg BI 730357 iCF (T2) / 200 mg BI 730357 TF1 (R2) | 200 mg BI 730357 TF1 (R2)/ 200 mg BI 730357 iCF (T2) | 100 mg BI 730357 Regularly Milled (R3)/ Coarse-milled (T3c)/ Unmilled (T3u) | 100 mg BI 730357 Coarse Milled (T3c) / Unmilled (T3u)/Regularly Milled (R3) | 100 mg BI 730357 Unmilled (T3u) /Regularly Milled (R3)/Coarse Milled (T3c) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 37.4 Years STANDARD_DEVIATION 8.5 | 36.6 Years STANDARD_DEVIATION 9.5 | 35.0 Years STANDARD_DEVIATION 9.5 | 29.3 Years STANDARD_DEVIATION 4.6 | 39.2 Years STANDARD_DEVIATION 8.3 | 26.0 Years STANDARD_DEVIATION 7 | 29.6 Years STANDARD_DEVIATION 4.6 | 33.5 Years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 7 Participants | 7 Participants | 4 Participants | 5 Participants | 5 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 5 Participants | 5 Participants | 5 Participants | 43 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 5 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 2 Participants | 4 Participants | 4 Participants | 1 Participants | 4 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 3 / 14 | 4 / 14 | 7 / 14 | 8 / 14 | 2 / 14 | 3 / 15 | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 14 |
Outcome results
Primary
Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.
Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| 50 mg BI 730357 iCF (T1) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 5870.79 nanomol*hours/Liter (nmol*h/L) |
| 50 mg BI 730357 TF1 (R1) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 5197.06 nanomol*hours/Liter (nmol*h/L) |
| 200 mg BI 730357 iCF (T2) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 19970.22 nanomol*hours/Liter (nmol*h/L) |
| 200 mg BI 730357 TF1 (R2) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 17292.36 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Unmilled API (T3u) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 5318.07 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Coarse-milled API (T3c) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 9028.63 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Regularly Milled API (R3) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 11568.30 nanomol*hours/Liter (nmol*h/L) |
Comparison: Relative bioavailabilityp-value: 0.041390% CI: [102.7, 124.26]ANOVA
Comparison: Relative bioavailabilityp-value: 0.077690% CI: [105.23, 126.74]ANOVA
Comparison: Relative bioavailabilityp-value: 0.644390% CI: [69.71, 87.38]ANOVA
Comparison: Relative bioavailabilityp-value: 190% CI: [41.05, 51.48]ANOVA
Primary
Maximum Measured Concentration of BI 730357 in Plasma (Cmax)
Maximum measured concentration of BI 730357 in plasma (Cmax).
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.
Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 50 mg BI 730357 iCF (T1) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 257.57 nanomol/Liter (nmol/L) |
| 50 mg BI 730357 TF1 (R1) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 178.10 nanomol/Liter (nmol/L) |
| 200 mg BI 730357 iCF (T2) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 605.33 nanomol/Liter (nmol/L) |
| 200 mg BI 730357 TF1 (R2) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 466.75 nanomol/Liter (nmol/L) |
| 100 mg BI 730357 iCF, Unmilled API (T3u) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 175.51 nanomol/Liter (nmol/L) |
| 100 mg BI 730357 iCF, Coarse-milled API (T3c) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 317.95 nanomol/Liter (nmol/L) |
| 100 mg BI 730357 iCF, Regularly Milled API (R3) | Maximum Measured Concentration of BI 730357 in Plasma (Cmax) | 423.42 nanomol/Liter (nmol/L) |
Comparison: Relative bioavailabilityp-value: 0.948590% CI: [124.82, 167.57]ANOVA
Comparison: Relative Bioavailabilityp-value: 0.781390% CI: [119.51, 140.73]ANOVA
Comparison: Relative Bioavailabilityp-value: 0.761690% CI: [64.58, 87.32]ANOVA
Comparison: Relative Bioavailabilityp-value: 190% CI: [35.61, 48.25]ANOVA
Secondary
Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 3 hours before and 0.5, 1, 1.5, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 hours after drug administration.
Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint that was not excluded due to a protocol deviation or due to PK non-evaluability. It was sufficient for each subject to contribute only 1 PK parameter value for 1 period.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| 50 mg BI 730357 iCF (T1) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 6222.62 nanomol*hours/Liter (nmol*h/L) |
| 50 mg BI 730357 TF1 (R1) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 5600.47 nanomol*hours/Liter (nmol*h/L) |
| 200 mg BI 730357 iCF (T2) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 21074.02 nanomol*hours/Liter (nmol*h/L) |
| 200 mg BI 730357 TF1 (R2) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 18464.52 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Unmilled API (T3u) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 5843.68 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Coarse-milled API (T3c) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 9585.79 nanomol*hours/Liter (nmol*h/L) |
| 100 mg BI 730357 iCF, Regularly Milled API (R3) | Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 11967.75 nanomol*hours/Liter (nmol*h/L) |
Comparison: Relative Bioavailabilityp-value: 0.009290% CI: [102.87, 120.01]ANOVA
Comparison: Relative Bioavailabilityp-value: 0.044290% CI: [104.58, 124.56]ANOVA
Comparison: Relative Bioavailabilityp-value: 0.492890% CI: [71.54, 89.68]ANOVA
Comparison: Relative Bioavailabilityp-value: 190% CI: [43.6, 54.69]ANOVA