Phase 1 N=36 Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
Healthy
Primary: Maximum Plasma Morphine Concentration — 4.60; 4.29 ng/mL
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Phase 1 N=36 Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Healthy
Primary: Maximum Plasma Morphine Concentration — 5.23; 4.15 ng/mL
Phase 1 N=48 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
Healthy
Primary: Bioequivalence Based on Cmax for Amoxicillin — 10970.75; 10867.32 ng/mL
Phase 1 N=24 Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 30.196; 30.892 ng/mL
Phase 1 N=24 Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 32.096; 31.753 ng/mL
Phase 1 N=22 Levetiracetam 1000 mg Under Non-Fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 26.320; 24.927 mcg/mL
Phase 1 N=30 Levetiracetam 1000 mg Under Fasting Conditions
Healthy
Primary: Cmax - Maximum Observed Concentration — 30.281; 31.512 mcg/mL
Phase 1 N=48 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
Healthy
Primary: Bioequivalence Based on Cmax for Amoxicillin — 7331.46; 7235.76 ng/mL
Phase 1 N=40 An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
HPV Infections
Primary: Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5…
Phase 1 N=40 Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril. — 21887.1; 23640.37 pg/mL
Phase 1 N=52 Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions
Healthy
Primary: Cmax (Maximum Observed Concentration) - Amoxicillin — 7800.48; 7599.29 ng/mL
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=40 Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril — 24243.26; 25646.69 pg/mL
Phase 1 N=40 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Healthy
Primary: Cmax (Maximum Observed Concentration) - Glipizide in Plasma — 337.100; 392.150 ng/mL
Phase 1 N=28 Ribavirin 200 mg Tablets Under Fasting Conditions
Healthy
Primary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — 518.357; 526.357 ng/mL