Clinical trials: Bioavailability and Pharmacokinetics
Healthy
Pharmacokinetics of Lidocaine in Healthy Adults
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo…
- Trial name
- NCT03310970
- Testing
- Lidocaine 5% patch, Lidocaine hydrochloride, Lidoderm 5% patch
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Nicole K Brogden
Healthy
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate…
- Trial name
- NCT02068690
- Testing
- BI 425809 PfOS, BI 425809 tablet
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects.
- Trial name
- NCT01540487
- Testing
- linagliptin/metformin(high dose), Linagliptin/metformin(low dose)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants.
- Trial name
- NCT05431153
- Testing
- Single dose of PF-07104091 as Tablet Formulation A (Treatment A), Single dose of PF-07104091 as Tablet Formulation B (Treatment B), Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood
The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894 and an unlabelled oral tablet formulation of…
- Trial name
- NCT04426851
- Testing
- BI 1358894, BI 1358894 (C-14) intravenous solution
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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.
Asthma, Healthy
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
- Trial name
- NCT00638989
- Testing
- CAT-354 150 mg (intravenous), CAT-354 150 mg (subcutaneous), CAT-354 300 mg (subcutaneous)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
- Trial name
- NCT02232178
- Testing
- 2 100mg Xaracoll implants, 3 100mg Xaracoll implants, 150mg Bupivacaine HCl injection
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Innocoll
Healthy Volunteers
A Study of Maribavir Pediatric Formulation in Healthy Adult Participants
The study will have 2 parts, Part 1 and Part 2. Participants will only participate in one part. The main aim of Part 1 of this study is to check the ability of a single dose of maribavir pediatric formulation to be absorbed in…
- Trial name
- NCT05918822
- Testing
- Maribavir Commercial Tablet Formulation, Maribavir Pediatric Powder-for-oral Suspension Formulation, Rabeprazole
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
Relative Bioavailability, AUC
Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions
This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2.
- Conditions
- Relative Bioavailability, AUC, Cmax, Pharmacokinetics
- Trial name
- NCT02359045
- Testing
- D1400147, D14000136, D14000137
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.
- Trial name
- NCT03467971
- Testing
- Metformin/Gliclazide Fixed Combination
- Where
- Mexico
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hernioplasty
Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open…
- Trial name
- NCT03234374
- Testing
- INL-001 (bupivacaine HCl collagen implant), Marcaine 0.25% infiltration
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Innocoll
Pulmonary Disease, Chronic Obstructive
Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients
The primary objective of this study is to assess the pharmacokinetics of tiotropium + olodaterol fixed-dose combination (FDC) (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady state in Chinese…
- Trial name
- NCT02969317
- Testing
- Tiotropium, Olodaterol
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Heart Failure
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure
The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic…
- Trial name
- NCT04384653
- Testing
- Furosemide Injection Solution for subcutaneous administration (80 mg), Furosemide Injection, USP, Medfusion 3500 (v6) precision infusion pump
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SQ Innovation, Inc.
Covid19
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy…
- Trial name
- COSMIC (NCT05280717)
- Testing
- sotrovimab
- Where
- 10 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Healthy
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects
- Trial name
- NCT01703858
- Testing
- BI 113608 PIB, BI 113608, pantoprazole 40 mg STADA
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus, HIV Infections
A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir
This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232.
- Trial name
- NCT03234036
- Testing
- GSK2838232 100 mg tablet, GSK2838232 50 mg capsule, Ritonavir 100 mg tablets
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline