Clinical trials: Bioavailability and Pharmacokinetics
Healthy
A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet
To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer
- Trial name
- NCT03804671
- Testing
- BI 730357, BI 730357 mixed with [C-14] BI 730357 BS
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Infections, Bacterial
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG])…
- Trial name
- NCT02853435
- Testing
- Gepotidacin RC Tablet, Gepotidacin HSWG Tablet, Gepotidacin Capsule
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Toxic Effect of Organophosphate and Carbamate Insecticides
Sublingual vs IV Atropine Bioavailability Study
This randomized, three-sequence, three-period, phase 1 study is designed to assess the bioavailability and pharmacokinetics (PK) of sublingually administered atropine sulfate ophthalmic solution 1% USP (at 0.5 mg and 1.0 mg…
- Trial name
- NCT04290039
- Testing
- Atropine Sulfate Ophthalmic Solution, Atropine Sulphate Injection
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Epilepsy
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
- Trial name
- NCT01364558
- Testing
- Diazepam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Anaemia
Absorption and Elimination of Radiolabeled Daprodustat
Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in previous clinical trials; however, the elimination routes and metabolic pathways of daprodustat have not been fully elucidated in humans.
- Trial name
- NCT03239522
- Testing
- [14C]-GSK1278863 solution for IV infusion, [14C]-GSK1278863 oral solution, Daprodustat 6 mg oral tablet
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.
This is a comparative bioavailability study to compare the pharmacokinetics and pharmacodynamic effects of Fluticasone propionate and Salmeterol delivered in a capsule-based inhaler versus a multi-dose dry powder inhaler in…
- Trial name
- NCT01494610
- Testing
- SERETIDE Rotacaps, SERETIDE Diskus
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Healthy
A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations
Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations
- Trial name
- ERBA (NCT05446142)
- Testing
- Encorafenib capsule formulation (CAP), Encorafenib first formulation, Encorafenib second formulation
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
A Study in Healthy Men to Test How Zongertinib (BI 1810631) is Taken up and Processed by the Body
Part A - the primary objective is to assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.
- Trial name
- NCT05879991
- Testing
- zongertinib (C-14), zongertinib
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects.
- Trial name
- NCT02690727
- Testing
- RP6530
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Rhizen Pharmaceuticals SA
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
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
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
- NCT02329834
- Testing
- Fursemide Injection Solution for subcutaneous administration (80 mg), Furosemide Injection, USP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- scPharmaceuticals, Inc.
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
Postoperative Pain
Pilot Herniorrhaphy Study for Postoperative Analgesia
A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal…
- Trial name
- NCT02504580
- Testing
- HTX-011, HTX-002, Bupivacaine HCI (Marcaine)
- Where
- 3 sites in United States
- Volunteers
- 463 people
- Sponsor
- Heron Therapeutics
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
Parkinson Disease
Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone
Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.
- Trial name
- NCT02305316
- Testing
- BIA 9-1067 non-micronized, BIA 9-1067 micronized
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
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