Clinical trials: Bioavailability and Pharmacokinetics
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
Healthy
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market.
- Trial name
- NCT05380947
- Testing
- BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), Rabeprazole sodium
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
- Trial name
- NCT02093819
- Testing
- BI 416970
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Severe Hypertriglyceridemia
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat…
- Trial name
- ECLIPSE (NCT01208961)
- Testing
- Epanova (4 g) and Lovaza (4 g), Lovaza (4 g) and Epanova (4 g)
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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 Subjects, Pharmacokinetics
A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil…
- Conditions
- Healthy Subjects, Pharmacokinetics, Bioavailability
- Trial name
- NCT00834288
- Testing
- Tramadol HCl
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.
Pulmonary Disease, Chronic Obstructive
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
This 2-part study will be carried out on healthy elderly subjects to evaluate relative bioavailability of danirixin formulations.
- Trial name
- NCT03457727
- Testing
- Danirixin, Omeprazole
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the…
- Trial name
- NCT04445090
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants
The Purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption, palatability of the selected pediatric formulation of maribavir and the safety…
- Trial name
- NCT04131556
- Testing
- Maribavir
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03210272
- Testing
- BI 1358894, BI 1358894 (Test), BI 1358894 (Reference)
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Peer Review, Research
Fentanyl Patch Pharmacokinetics 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 comparisons between RLD (reference listed drug) Duragesic ®…
- Trial name
- NCT02531971
- Testing
- Intravenous fentanyl citrate, Duragesic®, Mylan generic fentanyl
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy
This Study in Healthy Men Tests How the Body Takes up BI 1467335
The primary objective of this trial is to investigate the absolute bioavailability of BI 1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and an unlabelled oral tablet formulation of BI…
- Trial name
- NCT03483506
- Testing
- BI 1467335, BI 1467335 (C-14) intravenous solution
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
Healthy Participants
A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants
The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the…
- Trial name
- NCT06533475
- Testing
- Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition, Minzasolmin tablet formulation under fed condition
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
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
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Epilepsy
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or…
- Trial name
- NCT02279667
- Testing
- BIA 2-093
- Where
- Portugal
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy Participants
A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants. The study is seeking for participants who: are males aged 18 to 65 years and are healthy.
- Trial name
- NCT06267963
- Testing
- Oral [14C]PF-07220060, Oral PF-07220060, IV [14C] PF-07220060
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer