Clinical trials: Bioavailability and Pharmacokinetics
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects
This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two…
- Trial name
- NCT02648438
- Testing
- AZD7594 Solution for infusion (150 μg intravenous formulation), AZD7594 Oral suspension (1200 μg oral formulation), AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Healthy Volunteers
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
- Trial name
- NCT03010631
- Testing
- Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted, Cohort 2: Lubiprostone Sprinkle Formulation, Fed
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Sucampo Pharma Americas, LLC
Healthy Participants
A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.
This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of [14C]PF-06865571 following oral administration…
- Trial name
- NCT04866225
- Testing
- Oral [14C]PF-06865571, Oral PF-06865571, IV [14C]PF-06865571
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypogonadism
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
- Trial name
- NCT01323140
- Testing
- testosterone matrix transdermal system
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals
Non-Small Cell Lung Carcinoma (NSCLC), Colorectal Cancer (CRC)
Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment
This is a Phase 1/2, two-part, multi-arm, open-label study in patients with normal Hepatic Function (HF), with either Non-small cell lung cancer (NSCLC), who have had 1-2 prior lines of treatment, with 1 line containing a…
- Conditions
- Non-Small Cell Lung Carcinoma (NSCLC), Colorectal Cancer (CRC), Other Solid Tumors
- Trial name
- SPRINT (NCT04256707)
- Testing
- Selinexor 100 mg, Docetaxel, Pembrolizumab
- Where
- 11 sites in Israel
- Volunteers
- 80 people
- Sponsor
- Karyopharm Therapeutics Inc
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.
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 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
Healthy Volunteers
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral…
- Trial name
- NCT03811834
- Testing
- Mobocertinib
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Advanced Solid Tumors, Solid Tumors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft…
- Conditions
- Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04672460
- Testing
- TALZENNA capsule, Talazoparib soft gel capsule
- Where
- 31 sites in United States, Australia
- Volunteers
- 73 people
- Sponsor
- Pfizer
Healthy Volunteers
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg)…
- Trial name
- NCT04454918
- Testing
- TAK-906 Oral Capsule, [14C]-TAK-906 Intravenous Infusion, [14C]-TAK-906 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550.
- Trial name
- NCT05707403
- Testing
- BI 1015550, BI 1015550 mixed with [C-14]-BI 1015550
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a…
- Trial name
- NCT04992442
- Testing
- TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Hypercholesterolemia
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
This study aims to characterize the single dose pharmacokinetics of PF-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh.
- Trial name
- NCT02043301
- Testing
- Bococizumab (PF-04950615; RN316)
- Where
- 6 sites in United States
- Volunteers
- 75 people
- Sponsor
- Pfizer
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