Phase 1 N=15 Sublingual vs IV Atropine Bioavailability Study
Toxic Effect of Organophosphate and Carbamate Insecticides
Primary: Area Under the Curve to From Time Zero to Infinity (AUC_∞) — 286.396; 493.808; 816.465 min*ng/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=46 Sublingual Atropine Bioequivalence by Route of Administration (SABER)
Atropine Bioequivalence
Primary: The Bioequivalence of Atropine Sulfate Administered SL Versus Administered IM as Measured by Area Under the Analyte Concentration Versus Time Curve to Infinity (AUCinf)…
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=56 Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Healthy
Primary: Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) — 91; 80 picogram (pg)/millilitre (mL)
N/A N=6 Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Primary: Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery) — 46; 0 number of ventricular beats
Phase 1 N=48 Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Healthy
Primary: Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt) — 126.36; 129.48; 122.33; 119.75 ng*h/mL
N/A N=60 Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Healthy
Primary: Cmax — 812.477; 945.456 pg/mL — p=0.0328
Phase 4 N=76 Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Hypercholesterolemia
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity) — 18.3206; 19.2583 ng•hr/mL
N/A N=60 Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Healthy
Primary: Cmax — 996.998; 979.630 pg/mL — p=<0.0001
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=50 Nicotine Lozenge Bioequivalence Study
Smoking Cessation
Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] — 18.84; 20.71; 34.71; 33.68 nanogram (ng).hour (hr)/millilitre (mL)
Phase 4 N=76 Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Hypercholesterolemia
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity) — 168.1355; 176.1731 ng*hr/mL
Phase 3 N=999 Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma
Asthma
Primary: Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment — 4.03; 3.96 liters x hours
N/A N=40 Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Depression
Primary: Bioequivalence Determined by Statistical Comparison Cmax — 11.5; 11.3 ng/mL
Phase 1 N=32 Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants
Healthy
Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t)…
Phase 3 N=374 Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Chronic Obstructive Pulmonary Disease
Primary: Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose — 2.5644; 2.7370 L*hour
Phase 1 N=70 Relative Bioavailability of 2 Oral Formulations of Nintedanib
Healthy
Primary: AUC0-tz — 300; 310; 306 ng*h/mL — p=<0.0001
Phase 1 N=28 Amoxicillin Bioequivalence Study Brazil - Fast
Infections, Bacterial
Primary: Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t) — 36431.460; 40426.451 ng per hour per ml…
Phase 3 N=91 Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Mild Persistent Asthma
Primary: Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo — 0.608; 3.779; 4.432; 3.928 log(mg/mL) — p=<0.0001
Phase 3 N=1,550 Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
Bronchial Asthma
Primary: Change in FEV1 From Pre Dose to End of Treatment — 0.23; 0.22; 0.09 Litres
Phase 1 N=72 Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Healthy
Primary: Baseline Corrected Maximum Observed Plasma Concentration (Cmax[Adj]) of Levothyroxine Sodium — 67.258; 60.552 Nanogram per milliliter (ng/mL)
Phase 3 N=187 Low-Dose Atropine for Treatment of Myopia
Myopia
Primary: Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. — 0; 0; 1; 0 Participants
Phase 1 N=32 Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
Bioequivalence
Primary: Concentration Maximum (Cmax) — 0.9092; 0.8711 ng/ml
Phase 1 N=24 Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
Healthy
Primary: Cmax - Maximum Observed Concentration - Carvedilol in Plasma — 89.91; 97.05 ng/mL
Phase 1 N=58 Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Healthy
Primary: AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h) — 82517.99; 80641.47 pg*h/mL — p=<0.0001
Phase 1 N=36 Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
Healthy
Primary: Cmax - Maximum Observed Concentration - Carvedilol in Plasma — 104.98; 107.47 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
Phase 1 N=42 Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet
Malaria
Primary: Pyronaridine Pharmacokinetics: Tmax, Half-life — 0.184; 0.166; 14.2; 14.1 days
Phase 1 N=18 Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Bioequivalence, AUC, Cmax, Pharmacokinetics
Primary: Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) — 1920.362; 2096.669 ng*h/mL — p=0.05
Phase 1 N=34 Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Prostatic Hyperplasia
Primary: Cmax — 21700; 20520 pg/mL