Phase 4 N=23 Kaletra Sex/Gender Pharmacokinetics (PK) Study
HIV Infections
Primary: 24-hr LPV AUC — 142,160; 152140 ng*hr/mL
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Phase 3 N=2,133 Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Diphtheria · Tetanus · Pertussis
Primary: Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T…
Phase 1 N=24 Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Healthy
Primary: AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose — 2794.93; 2580.06; 2497.71 mmHg*min
Phase 1 N=24 Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
Healthy
Primary: Maximum Plasma Concentration (Cmax) — 177.69; 172.64 ng/ml
N/A N=23 Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
Hypertriglyceridemia
Primary: Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). — 3.2; 3.3 Index value — p=0.959
Phase 2 N=47 Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Healthy Subjects
Primary: Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers — 1282.059; 2550.727; 60046.128; 48428.635 pg/ml
Phase 1 N=54 QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Healthy
Primary: Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes — 408.8; 409.6; -4.7; -4.6 milliseconds
Phase 1 N=24 Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Healthy
Primary: Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration — 2582.507; 2495.100; 27771.234 pg/ml
Phase 2 N=48 Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Neoplasms, Unknown Primary
Primary: Progression Free Survival — 3.7 months
Phase 2 N=30 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Esophagitis
Primary: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups — 0.6; -7.5 perecentage of eos per…
Phase 4 N=220 Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Relapsing-remitting Multiple Sclerosis
Primary: Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection — 31; 37 Percentage of sites
Phase 2 N=51 A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
Infection, Human Immunodeficiency Virus
Primary: Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11 — 21; 23 Participants
Phase 1 N=65 First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Inflammation · Rheumatoid Arthritis
Primary: Frequency of Adverse Events — 5; 4; 3; 4 events
Phase 2 N=103 A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Rheumatoid Arthritis
Primary: Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine — 39.1; 42.3 Percentage of patients
Phase 4 N=423 Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Tetanus · Diphtheria · Pertussis
Primary: Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine — 172; 177; 196; 194…