Phase 4 N=12 Bioavailability Study for New Atorvastatin Formulation
Hypercholesterolemia
Primary: Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48) — 135.05; 140.79 ng.h/mL
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=56 Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Healthy
Primary: AUC0-∞ — 3960; 3400; 3350; 3420 ng*h/mL
Phase 1 N=18 Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers
Healthy
Primary: AUC0-∞ — 10600; 12400; 13600 nmol*h/L
Phase 1 N=33 Bioavailability of Apixaban Crushed Tablet
Thrombosis
Primary: Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban — 236; 249; 186 ng/mL
Phase 1 N=30 Bioavailability of Different Applications of Dabigatran in Healthy Volunteers
Healthy
Primary: AUC0-inf for Total Dabigatran — 599; 1050; 928 ng(nanogram)*h(hour)/mL(milliliter)
N/A N=48 Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment
Human Gastrointestinal Physiology Data
Primary: Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen — 5.12; 5.36 pH
Phase 1 N=9 This Study in Healthy Men and Women Tests How the Body Takes up BI 409306
Healthy
Primary: Area Under the Concentration-time Curve of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)…
Phase 1 N=20 Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)
Hereditary Tyrosinemia, Type I
Primary: Maximum Observed Plasma Concentration (Cmax) — 1168.23; 1054.32 ng/mL
Phase 1 N=24 Bioavailability Study of COQUN ORAL FORMULATION
Male & Female Healthy Volunteers
Primary: Analysis of Pharmacokinetic Property "Area Under the Curve" — 2657.45; 3459.05 microg/l*days
Phase 1 N=30 Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers
Healthy Volunteers
Primary: Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate — 27.0; 36.0; 38.3 ng*hr/ml
Phase 1 N=12 Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
Parkinson
Primary: Cmax - Maximum Observed Plasma Concentration — 635.0; 238.2 ng/mL
Phase 1 N=23 Bioavailability of Belumosudil (KD025) in Healthy Male Subjects
Bioavailability
Primary: Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose — 821; 2100…
Phase 1 N=18 Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Epilepsy
Primary: Cmax - the Maximum Plasma Concentration — 18048; 16007; 17042 ng/mL
Phase 1 N=8 A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
Healthy
Primary: Dose Normalized Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) — 118.27; 161.69…
Phase 1 N=12 This Study in Healthy Men Tests How the Body Takes up BI 1467335
Healthy
Primary: After the First Dose: Area Under the Concentration-time Curve of BI 1467335 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of BI 1467335 (After…
Phase 1 N=18 Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
Healthy Participants
Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib — 3312; 3205; 3161 nanogram•hour per milliliter (ng•hr/mL)
Phase 1 N=18 Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
Healthy Volunteers
Primary: AUC0-tz of BI 1467335 — 3.90; 2.24; 2.49 nanomole*hour/Liter (nmol*h/L)
Phase 1 N=22 Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)
Malaria
Primary: OZ439 AUC(0-168h) — 8780; 10300; 9460 ng*h/mL
Phase 1 N=12 A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood
Healthy
Primary: Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm) — 44.63; 0.22…
N/A N=10 Matrix on Fruit Constituent Bioavailability
Healthy Non-smoker
Primary: CMax in Polyphenol Anthocyanin Concentrations — 8.7; 22.1; 7.6; 11.3 nmol/L
Phase 1 N=18 Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
Healthy Adult Male
Primary: Maximum Plasma Concentration (Cmax) of OPC-34712 — 47.4; 44.9; 46.1 ng/mL
Phase 1 N=6 Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
Healthy Volunteers
Primary: Absolute Bioavailability of PBT2 (F%) — 15.936 percentage of absolute bioavailability
Phase 1 N=48 Bioavailability Study of 2 Oral Formulations of ALXN1840
Healthy
Primary: Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo) — 227.0186; 238.2725 nanograms (ng)/milliliter (mL)
Phase 1 N=6 A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
Healthy
Primary: Area Under the Concentration-time Curve of the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time…
Phase 1 N=18 Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Healthy Volunteers
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 307.225; 324.324; 330.411 hr*ng/mL
Phase 1 N=24 A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food
Healthy
Primary: Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 2290; 2740; 3000…
Phase 1 N=12 Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
Healthy
Primary: Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 4164.32; 4057.42…
Phase 1 N=16 Bioavailability Study of Colcrys® in Apple Juice
Healthy
Primary: Maximum Plasma Concentration (Cmax) — 2.407; 2.122 ng/mL
Phase 1 N=14 Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Healthy Volunteers
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 401.655; 360.619 hr*ng/mL
Phase 1 N=12 A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood
Healthy
Primary: Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration…