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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=24 Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Asthma
Primary: Area Under the Plasma Concentration-time Profile From Time 0 the Last Quantifiable Concentration (AUC0-last) With Dose Normalization — 658; 700; 716; 748 pg.h/mL…
N/A N=26 Bioequivalence Study of Letrozole 2.5 mg Tablets
Healthy
Primary: Letrozole : AUC0-tz — 2074.71; 2094.63 ng•hr/mL
Phase 1 N=72 Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
Healthy
Primary: Maximum Measured Concentration (Cmax) of the Analytes in Plasma — 697; 726; 3.62; 3.57 ng/mL
Phase 2 N=59 Pharmacokinetics of Advantage Arrest in Children
Dental Caries
Primary: Predicted Peak Serum Silver Concentration (Cmax) — 17.8 ng/ml
Phase 2 N=39 Pharmacokinetic Study of Testosterone Enanthate
Hypogonadism
Primary: The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks — 150445.2; 70955.7; 278657.9…
Phase 1 N=42 Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Healthy Volunteers
Primary: Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)] — 18.96; 10.47 nanograms*hours/mL…
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=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
Phase 1 N=72 Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Hypertension · Heart Failure
Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin — 85.77; 88.37; 92.39; 192.3 nanogram*hour per…
Phase 1 N=64 Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
Human Immunodeficiency Virus Type 1 (HIV-1)
Primary: Maximum Observed Plasma Concentration (Cmax) of Atazanavir — 3832; 4104; 2585; 2941 ng/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)
N/A N=35 Bioequivalence Study on Vitamin C in Healthy Adults
Dietary Exposure
Primary: Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)] — 1114.66; 1149.09 μmol*min/L
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=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=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=60 Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation
Epilepsy
Primary: Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005 — 7107.7; 10724.8; 13186.4; 6660.3 ng/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 4 N=34 Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns
Depression
Primary: Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage — 469; 667; 706; 1002…
Phase 1 N=18 A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
Healthy
Primary: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With…
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=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=146 Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
Healthy Volunteer
Primary: Maximum Observed Drug Concentration (Cmax) of Denosumab — 12.7; 11.8 μg/mL
Phase 1 N=18 Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
Healthy
Primary: Maximum Plasma Concentration (Cmax) — 270.31; 248.46 ng / ml
Phase 1 N=16 Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
Healthy
Primary: Cmax of Aramchol — 3.334; 2.057; 0.668 µg/mL
Phase 1 N=26 Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Healthy
Primary: Maximum Plasma Concentration (Cmax) — 265.96; 260.04 ng/ml
Phase 1 N=28 Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Type 2 Diabetes
Primary: Area Under the Curve (AUC(0-t)) for Sitagliptin — 1570; 1590; 1520; 1600 hr*ng/mL
Phase 1 N=60 Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
Hepatitis C
Primary: Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) — 17297.157; 17216.514 ng·h/mL
Phase 4 N=20 Triomune Bioequivalence With Innovators
HIV/AIDS
Primary: Area Under the Concentration-Time Curve(AUC) — 3.6; 3.4; 85.8; 79.2 hour*milligram/liter
Phase 3 N=31 Pharmacokinetic Comparison Of All FK-506 Formulations
Renal Failure
Primary: Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf. — 5.91; 1.93; 1.48 hour