Attention Deficit Hyperactivity Disorder (ADHD)

Binge-Eating Disorder Disorder

dasotraline

Clinical Pharmacology of Miami, Inc.

Orlando Clinical Research Center

Atlanta Center for Medical Research

DaVita Clinical Research

American Research Cororation (ARC), Texas Liver Instituete (TLI)

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

Pharmacokinetics of Orally Administered Dasotraline in Subjects With Mild, Moderate, and Severe Hepatic Dysfunction

Plasma PK parameters: Area under the plasma/serum concentration-time curve from time zero to infinity (AUC0 inf)

Plasma PK parameters: time of occurrence of Cmax

Urine PK parameters: amount excreted in urine from time zero to time t (AEx0 t)

Urine PK parameters: renal clearance (CLR)

Urine PK parameters: percent of dose excreted in urine (%fe)

Unbound fraction of dasotraline in plasma at 10, 12, and 24 hours postdose .

Incidence of adverse events (AEs), SAEs, and AEs resulting in study discontinuation.

Absolute values and changes from baseline in clinical laboratory tests (hematology, serum chemistry, urinalysis, prothrombin time), vital signs (respiratory rate, body temperature, supine blood pressure, and supine pulse rate), and 12 lead ECGs.

Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS).

Plasma PK parameters: AUC0-last, area under the blood concentration time curve from time zero to 24 hours postdose (AUC0-24)

Plasma PK parameters: time of occurrence of Cmax (tmax)

Plasma PK parameters: apparent clearance (CL/F)

Plasma PK parameters: apparent volume of distribution (Vz/F)

Sunovion

Drug: N-acetylcysteine placebo and Drug: Silibin placebo

Drug: N-acetylcysteine and Drug: Silibin placebo

Drug: N-acetylcysteine placebo and Drug: Silibin active

Drug: N-acetylcysteine active and Drug: Silibin active

Drug: N-acetylcysteine active and Drug: Silibin higher dose active

N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months

NAC Placebo and Silibin Placebo

N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months

NAC Active and Silibin Placebo

N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months
(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo
(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months

NAC Placebo and Silibin Active

N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo
N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months
(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months
(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months

NAC Active and Silibin Active

N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months

NAC Active and High-dose Silibin Active

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Systolic BP

Diastolic BP

Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.

NAC Placebo + Silibin Placebo

NAC Active + Silibin Placebo

NAC Placebo + Silibin Active

NAC Active + Silibin Active

NAC Active + High-dose Silibin Active

Change From Baseline in Urinary Albumin Excretion

Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods

Change From Baseline in Hemoglobin-A1c

Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analyzed.

Drug: N-acetylcysteine placebo and Drug: Silibin placebo
N-acetylcysteine placebo and silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months

Drug: N-acetylcysteine and Drug: Silibin placebo
N-acetylcysteine active and silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months

Drug: N-acetylcysteine placebo and Drug: Silibin active
N-acetylcysteine placebo and silibin active: Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months

Drug: N-acetylcysteine active and Drug: Silibin active
N-acetylcysteine active and silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months

Drug: N-acetylcysteine active and Drug: Silibin higher dose active
N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months

Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines

NAC Active + High Dose Silibin Active

Overall Study

Dr. Shweta Bansal

Diabetic Nephropathy

Proteinuria

Oxidative Stress

Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months

N-acetylcysteine placebo and silibin placebo

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months

N-acetylcysteine active and silibin placebo

Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months

N-acetylcysteine placebo and silibin active

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months

N-acetylcysteine active and silibin active

Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months

lamyropsis microcephala/albumiini

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy

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