N/A N=82 Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
Epilepsy
Primary: Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=288 Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
Primary: Relative Change From Baseline in Duration of Morning Stiffness at Week 12 — -22.7; -0.4 percent change
Phase 4 N=12 Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Gastroparesis · Gastroesophageal Reflux Disease
Primary: Time to Maximal Omeprazole Concentration (Tmax) — 32; 97 minutes — p=< 0.01
Phase 1 N=36 Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
Healthy
Primary: Maximum Plasma Morphine Concentration — 37.5; 38.0 ng/mL — p=<0.05
Phase 3 N=29 Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
End Stage Renal Disease · Rejection of Renal Transplant
Primary: Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant — 2.03; -2.19 mL/min/1.73m^2
Phase 1 N=42 Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
Type 2 Diabetes Mellitus
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] — 10690; 3187; 2725; 3430 nanogram*hour/milliliter (ng*hr/mL)
Phase 1 N=26 A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)
Healthy
Primary: Bioequivalence Based Cmax — 1230.7; 2947.7 ng/mL
Phase 2 N=20 Oral Liquid 13-cis-retinoic Acid (13-CRA)
Neuroblastoma
Primary: Relative Bioavailability — 10009.0; 6075.9 (h.ng/mL)
Phase 1 N=16 A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772
Autoimmune Diseases
Primary: Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation — 14.355 Hours*microgram per milliliter
Phase 3 N=135 Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Restless Legs Syndrome · Restless Legs Syndrome (RLS)
Primary: Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period — 9; 14; 10; 11 Participants
N/A N=30 Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers
Diabetes Mellitus, Type 2
Primary: Maximum Observed Concentration (Cmax) — 884.297; 963.384; 942.653 Nanograms per milliliter (ng/mL) — p=0.1413
Phase 2 N=205 Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Postmenopausal Osteoporosis
Primary: Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population — -41.235…
Phase 1 N=36 Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fed Conditions
Healthy
Primary: Mean Maximum Plasma Morphine Concentration — 37.3; 32.8 ng/mL
Phase 3 N=53 Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Chronic Iron Overload
Primary: Overview of Number of Participants With Adverse Events — 52; 20; 14; 2 number of participants
Phase 1 N=54 Riluzole Orodispersible Film Replicate Bioavailability
Healthy Participants
Primary: Evaluation of the Bioequivalent Rate of Absorption (Cmax) of Riluzole After Replicate Single Dose Administration of Test and Reference — 315.62; 278.81 ng/mL — p=<0.0001
Phase 1 N=36 Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions
Healthy
Primary: Maximum Plasma Morphine Concentration — 42.8; 46.8 ng/mL
Phase 1 N=81 GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study
Healthy
Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Metformin — 3627.171; 4076.521; 6981.833; 6564.938…
Phase 3 N=209 A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Primary: Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 — -2.43; -2.85 units on a scale
Phase 2 N=32 A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules
Schizophrenia Schizoaffective
Primary: Participants With at Least One Treatment Emergent Adverse Event (TEAE). — 10; 8; 18; 1 Number of Participants with TEAEs
Phase 1 N=56 Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Epilepsy
Primary: Cmax - Maximum Observed Plasma Concentration of 9-1067 — 600; 567; 955; 917 ng/mL
Phase 1 N=22 Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
Healthy
Primary: Cmax - Maximum Observed Concentration — 1515.00; 1464.10 ng/mL
Phase 3 N=416 Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
Depressive Disorder
Primary: Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8 — -10.4; -12.8; -12.5 scores on a scale — p=<0.001
Phase 1 N=18 A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet
Sickle Cell Disease
Primary: Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)…
Phase 1 N=30 A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State
Healthy Subjects · Bioavailability · Pharmacokinetics
Primary: Bioequivalence Based on Cmax,ss — 1812.026; 3117.778 ng/mL
Phase 4 N=15 Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
Attention-deficit/Hyperactivity Disorder · Autism Spectrum Disorder
Primary: Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score — -22.8 units on a scale
Phase 1 N=32 15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — 26345.06; 25942.77 pg/mL
Phase 1 N=26 Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Pain
Primary: AUC(0-t) — 5886; 4761 ng.h/mL
Phase 1 N=32 15 mg Mirtazapine Orally Disintegrating Tablets, Fasting
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — 32975.95; 33122.52 pg/mL
Phase 1 N=48 Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
Healthy
Primary: Maximum Observed Plasma Concentration (Cmax) of Metformin — 1109; 1087 Nano-gram per milliliter (ng/mL)
Phase 4 N=532 Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 — -1.61; -1.58 Percentage of HbA1c