Clinical trials: Bioavailability and Pharmacokinetics
Healthy Volunteers
Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector
To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous…
- Trial name
- NCT05264493
- Testing
- NaxRedy ™, Naloxone Hydrochloride Injection, USP
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
The primary objective of this study is to evaluate the safety and tolerability of single doses of BIIB061 administered to healthy adult volunteers.
- Trial name
- NCT02071121
- Testing
- BIIB061, 14C-BIIB061
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy Male Participants
A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients
The purpose of this study is to evaluate the absolute bioavailability and pharmacokinetics (what the body does to the medication) of simeprevir (TMC435) after administration of single oral doses of 50 mg and 150 mg when…
- Trial name
- NCT01707342
- Testing
- Simeprevir (TMC435)
- Where
- Belgium
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Bioavailability of ASP015K, Healthy Subjects
A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation.
- Conditions
- Bioavailability of ASP015K, Healthy Subjects, Pharmacokinetics of ASP015K, Food Effect of ASP015K
- Trial name
- NCT01929577
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Diabetes
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of…
- Trial name
- NCT01240980
- Testing
- BMS-903452
- Where
- 2 sites in United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects.
- Trial name
- NCT01971502
- Testing
- BI 1060469
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
The objective of the present study is to investigate the relative bioavailability of two BIIL 284 BS tablets (tablet C and tablet C) in comparison to the WIF tablet at a dose of 75 mg following a standard breakfast in healthy…
- Trial name
- NCT02265653
- Testing
- BIIL 284 BS tablet C, BIIL 284 BS tablet D, BIIL 284 BS WIF tablet
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults.
- Trial name
- NCT02919319
- Testing
- ACT-541468 (Formulation A), ACT-541468 (Formulation B), 14C-labeled ACT-541468
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Iron-refractory, Iron-deficiency Anemia (IRIDA)
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
- Trial name
- NCT02767128
- Testing
- Triferic, Fer-In-Sol, Shohl's solution
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
Healthy
A Study to Test How BI 1819479 is Taken up and Processed by the Body
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
- Trial name
- NCT07065617
- Testing
- [14C]BI 1819479, BI 1819479, BI 1819479 (C-14)
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anaemia
Relative Bioavailability Study for GSK1278863A
A randomized, open-label, 3-period crossover study.
- Trial name
- NCT01319006
- Testing
- GSK1278863A
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Community-acquired Infection
A Four Part Study to Investigate Relative Bioavailability, Safety and Tolerability of up to 5 Oral Formulation of GSK2251052 in Order to Identify a Formulation for Further Evaluation in a Future Later Phase Study
GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with tRNA and is currently in development for the…
- Trial name
- Relative Bio (NCT01702350)
- Testing
- GSK2251052
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation
The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to…
- Trial name
- NCT02945007
- Testing
- JNJ-53718678
- Where
- Belgium
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).
- Trial name
- NCT01843972
- Testing
- BI 691751
- Where
- Germany
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Trial name
- NCT07636928
- Testing
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
A Phase I Study of LX22001 for Injection in Healthy Subjects
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.
- Trial name
- NCT06561542
- Testing
- LX22001 for Injeciton, Tegoprazan tablet, Esomeprazole sodium for injection
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
COVID-19, Coronavirus Infection
Relative Bioavailability Study of CX2101A for the Treatment of COVID-19
The study comprises three parts: single ascending dose (SAD) studies of CX2101A tablets at 40 mg, 100 mg, and 160 mg; a relative bioavailability (BA) study comparing single-dose administration of 100 mg CX2101A tablets and…
- Trial name
- NCT06864182
- Testing
- CX2101A tablet, CX2101A enteric-coated tablet
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Heronova Pharmaceuticals
Healthy
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
- Trial name
- NCT02442310
- Testing
- Deferiprone delayed release tablet formulation, Deferiprone oral solution
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Stable Renal Transplant Recipients
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®.
- Trial name
- NCT00991510
- Testing
- mycophenolate mofetil (Myfenax), mycophenolate mofetil (Cellcept)
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Bioavailability of ASP015K, Pharmacokinetics of ASP015K
A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of…
- Conditions
- Bioavailability of ASP015K, Pharmacokinetics of ASP015K, Healthy Subjects
- Trial name
- NCT01486017
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc