Phase 1 N=36 Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
Type 2 Diabetes Mellitus
Primary: Saxagliptin Maximum Observed Concentrations (Cmax) — 26.2; 25.5 ng/mL — p=0.4950
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=67 Bioequivalence Study of Tacrolimus in Healthy Volunteers
Healthy Volunteers
Primary: Area Under the Concentration (AUC 72) — 37434.51; 33716.80 pg.h/mL
Phase 1 N=56 Dose-finding Pharmacokinetic Study in Healthy Males
Healthy Volunteers
Primary: Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24) — 4300; 5423; 7439; 9046 h*ng/ml
Phase 1 N=84 Clopidogrel Bioequivalence Study in Healthy Subjects
Bioequivalence, AUC, Cmax, Pharmacokinetics
Primary: Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) — 1.05; 0.992; 1.09 ng*h/mL
N/A N=28 Bioequivalence Study for Mejoral 500 Product
Pain
Primary: Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)] — 15.212; 14.698 hours*microgram/millilitre (h*μg/mL)
Phase 1 N=80 A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
Bioequivalence · Fixed Dose Combination Tablets · Healthy Male and Female Subjects
Primary: Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State — 236.3; 248.6; 251.6; 258.2 h*ng/mL
Phase 1 N=32 Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
Healthy
Primary: AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) — 6260; 6360 ng*h/mL…
Phase 1 N=85 Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Parkinson
Primary: Cmax - Maximum Observed Plasma Concentration — 107.3; 95.5; 424.5; 471.0 ng/mL
Phase 2 N=34 Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Healthy Volunteers
Primary: Area Under the Curve of Plasma Naproxen From 0 to t — 67763.0; 69427.9 min×μg/mL
Phase 1 N=49 A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
Healthy Volunteers · Male · Japanese
Primary: Area Under the Serum Concentration-time Curve From Time Zero to Infinity [AUC(0-∞)] — 30200000; 29000000 ng*h/mL
Phase 1 N=64 A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
Healthy
Primary: Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 1270.92; 1320.24…
Phase 1 N=28 A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
Healthy Volunteers
Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 85020; 90030; 16220; 16120 (nanogram*hour) per milliliter (ng*h/mL)
Phase 2 N=143 Evaluate Safety, Efficacy and Pharmacokinetics
Metastatic Breast Cancer
Primary: Area Under the Concentration Time Curve at Steady State (AUCss) — 34400; 31800 ug*h/mL
Phase 1 N=64 A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Healthy
Primary: Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 2275.77; 2166.70…
Phase 1 N=48 Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)
no Condition
Primary: Cmax of NAC After Single Dose Administration of Test and Reference — 2804.38; 3215.63 ng/mL — p=0.0136
Phase 1 N=96 Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
Healthy
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…
Phase 1 N=25 Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Healthy
Primary: Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 6147; 6141 nanomol…
Phase 1 N=35 A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects
Pain
Primary: The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast]) — 47.18…
Phase 1 N=40 Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate
Epilepsy
Primary: Cmax - Maximum Plasma Concentration — 6461; 13183; 6547; 12988 ng/ml
Phase 1 N=42 A Bioequivalence (BE) Study in Healthy Subjects
Attention Deficit Hyperactivity Disorder
Primary: Maximum Observed Plasma Concentration (Cmax) — 456; 483 nanogram per millileter (ng/mL)
Phase 1 N=42 Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
Healthy Adult Subjects
Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone After Oral and…
Phase 1 N=28 Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Parkinson Disease
Primary: Cmax - Maximum Observed Plasma Concentration — 327.8; 750.1 ng/mL
Phase 1 N=28 Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
Bioequivalence · Healthy Subjects
Primary: Maximum Plasma Concentration (Cmax) — 1948.656; 1916.300 ng/mL
Phase 1 N=52 A Bioequivalence Study of TAK-536 Pediatric Formulation
Japanese Healthy Adult Males
Primary: AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort — 7065.6; 7341.2 nanogram*hour per milliliter…
Phase 1 N=324 Pharmacokinetics and Safety in Healthy Volunteers
Healthy
Primary: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® — 2630; 2470; 2650 microgram…
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=97 Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers
Healthy
Primary: Number (%) of Subjects With Drug-related Adverse Events — 28.0; 51.9; 33.3; 92.6 Percentage of participants
Phase 1 N=56 Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
Helminthiasis
Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole. — 54.82; 48.07 nanogram (ng).hr per milliliter (mL)
Phase 1 N=30 A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
Healthy
Primary: Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C — 10920; 10720; 11200…
Phase 1 N=28 Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Type 2 Diabetes Mellitus
Primary: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) — 7062.76; 7187.14…