Clinical trials: Evaluate PK Profile
Healthy Women, Female Contraception
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary…
- Trial name
- NCT04143659
- Testing
- levonorgestrel butanoate (LB) injection
- Where
- 7 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Premier Research
Contraceptive Usage
A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception
To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).
- Trial name
- CCN011 (NCT02173808)
- Testing
- levonorgestrel butanoate
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Premier Research
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Lung Cancer, Oral Cancer
Exploratory Study of Inhaled Afatinib Dimaleate PK Profile
This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared…
- Conditions
- Lung Cancer, Oral Cancer, Melanoma
- Trial name
- EDDIS-a1 (NCT06897735)
- Testing
- Afatinib Dimaleat, inhalation of afatinib dimaleate
- Where
- New Zealand
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Petrov, Andrey
Healthy Males
Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations
This is a single-centre, open-label, non-randomised, period fixed sequence study designed to investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet formulations and compare this to a reference…
- Trial name
- NCT03714685
- Testing
- Firibastat
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Quantum Genomics SA
Pain
A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects
The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.
- Trial name
- NCT04862884
- Testing
- HRS4800 tablets
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- Trial name
- NCT04865536
- Testing
- TBI-223 1800 mg, TBI-223 2400mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Healthy
Effect of Food Intake on Pharmacokinetic Profiles of Z-338
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.
- Trial name
- NCT00920998
- Testing
- Z-338
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Helicobacter Pylori Infection
A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects
This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study.
- Trial name
- NCT06190340
- Testing
- TNP-2092 capsules
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Evaluate PK Profile, Evaluate PD Profile
A Study Testing the Effects of Different THC Doses on Psychological and Biological Function
The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in healthy adults with prior cannabis use experience.
- Conditions
- Evaluate PK Profile, Evaluate PD Profile, Healthy Adults, Safety and Tolerability in Healthy Volunteers
- Trial name
- DRATT (NCT07346690)
- Testing
- AVCN319301b (6mg), AVCN319301b (9mg), AVCN319301b (15mg)
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Alzheimer's Disease
Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation
The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.
- Trial name
- NCT02710188
- Testing
- HTL0009936 modified release, HTL0009936 immediate release
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Healthy
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
- Trial name
- NCT01243580
- Testing
- Ortho-Cyclen, AG200-15
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Healthy, Multiple Sclerosis
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers…
- Trial name
- NCT01610310
- Testing
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Biogen
Hyperammonemia
A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules
The aim of the study was to evaluate the tolerability and pharmacokinetic characteristics of TNP-2092 Capsules after single-dose administration in healthy subjects, and the food effect on pharmacokinetics.
- Trial name
- NCT06178718
- Testing
- TNP-2092 capsules
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Asthma
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the…
- Trial name
- NCT01737892
- Testing
- Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Healthy Subjects
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single…
- Trial name
- NCT03279302
- Testing
- Glepaglutide
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Healthy
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.
- Trial name
- NTC00940472 (NCT01560481)
- Testing
- Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose, Step A: metformin glycinate 2480 mg single dose
- Where
- Spain
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Idiopathic Pulmonary Fibrosis (IPF)
To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers
This is a Phase I stage to investigate the safety and tolerability of MG-S-2525 in healthy volunteers. The proposed trial consists of 3 study parts to be conducted at Tri-Service General Hospital and includes Single Ascending…
- Trial name
- NCT03650075
- Testing
- MG-S-2525
- Where
- Taiwan
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Metagone Biotech Inc.
Pharmacokinetics
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
This is an open-label, randomized, single-dose, three treatment, three-period crossover study comparing the test and reference products under fasted or fed conditions (as applicable).
- Trial name
- NCT05232461
- Testing
- PrimeC-ER 748 mg, Ciprofloxacin 750 MG, Celecoxib 200mg
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NeuroSense Therapeutics Ltd.
Healthy
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.
- Trial name
- NCT03830463
- Testing
- CTP-692
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals