Clinical trials: Area Under Curve
Healthy
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants.
- Trial name
- NCT04111614
- Testing
- Tofacitinib tablet, Tofacitinib Oral Solution
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
COPD
TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD
Efficacy of TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on lung stiffness reduction assessed through area under the reactance curve (AX) using oscillometry in chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT04671355
- Testing
- Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg, Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg
- Sponsor
- Chiesi Farmaceutici S.p.A.
Ornithine Transcarbamylase Deficiency
A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects
The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.
- Trial name
- NCT04269122
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ultragenyx Pharmaceutical Inc
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Solid Tumours
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating and the effect of olaparib on QT…
- Trial name
- NCT01921140
- Testing
- Olaparib tablets, Pharmacokinetic sampling, Dietary Fasted
- Where
- 12 sites in Belgium, Denmark and 2 more
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Healthy Participants
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy…
- Trial name
- NCT04916769
- Testing
- Bosutinib capsule
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Solid Tumours
D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours
This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie…
- Trial name
- NCT01851265
- Testing
- Olaparib, Dietary Fasted, Dietary standard
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Nonhematologic Malignancies, Lymphoma
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2)…
- Trial name
- NCT01454076
- Testing
- Ixazomib 2.5 mg, Ixazomib 4 mg Capsule A, Ixazomib 4 mg Capsule B
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc.
- Trial name
- NCT02465866
- Testing
- CL-108, Vicoprofen, Ultracet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
Sjögrens Disease, Systemic Lupus Erythematosus
Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL…
- Conditions
- Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Trial name
- NCT06293365
- Testing
- VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
- Where
- 37 sites in United States, Argentina and 6 more
- Volunteers
- 155 people
- Sponsor
- Novartis Pharmaceuticals
Pharmacokinetics
Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.
- Trial name
- NCT01721070
- Testing
- Sufentanil NanoTab (SUF NT) 15 mcg, Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Pharmacokinetics
Effect of Delivery Route on PK of Sufentanil NanoTab
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.
- Trial name
- NCT01639729
- Testing
- Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow…
- Trial name
- NCT01894256
- Testing
- Olaparib tablet dosing
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 56 people
- Sponsor
- AstraZeneca
Healthy Participants
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie…
- Trial name
- NCT05032690
- Testing
- Bosutinib capsule, Bosutinib
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening…
- Trial name
- NCT01424956
- Testing
- Automated Breast Ultrasound (ABUS)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- U-Systems, Inc.
Infantile Spasms
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.
- Trial name
- NCT01413711
- Testing
- Vigabatrin
- Sponsor
- Lundbeck LLC