Clinical trials: Single Dose
Healthy
Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fed conditions.
- Trial name
- NCT00648154
- Testing
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers (HV)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers
Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
- Trial name
- NCT07618156
- Testing
- KR25102 for Injection
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
Type 2 Diabetes Mellitus
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes.
- Trial name
- NCT00894322
- Testing
- exenatide once weekly
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy
Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers
The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a…
- Trial name
- NCT02183428
- Testing
- BI 1356, Glyburide, BI 1356 + Glyburide
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hyperkalemia
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels
- Trial name
- Redukx (NCT04780841)
- Testing
- RDX013
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Ardelyx
Chronic Hepatitis B
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects.
- Trial name
- NCT05569941
- Testing
- ABI-4334 Tablet
- Where
- New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Sinusitis
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To
To measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets for up to 3 days.
- Trial name
- NCT00232154
- Testing
- Zithromax™ (azithromycin) 500mg tablets, Endoscopic Sinus Surgery, Blood sampling for hematology
- Where
- 18 sites in United States
- Volunteers
- 72 people
- Sponsor
- Pfizer
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
- Trial name
- NCT07222254
- Testing
- AZD0292
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Inflammation, Rheumatic Diseases
Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It is characterized by inflammation of the spinal joints that can lead to severe pain, and in more advanced…
- Trial name
- NCT04205851
- Testing
- KIN-1901
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Kinevant Sciences GmbH
Impaired Hepatic Function
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States.
- Trial name
- NCT02135302
- Testing
- eravacycline
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal…
- Trial name
- NCT03482453
- Testing
- TAK-788
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Smoking
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
- Trial name
- NCT02633839
- Testing
- CVT-301, Carbidopa
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Acorda Therapeutics
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated
The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers.
- Trial name
- NCT06081530
- Testing
- BI 3802876
- Where
- Belgium
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pancreatic Cancer
Safety and Efficacy Study of 90Y-hPAM4 at Different Doses
Safety study to determine highest dose of 90Y-hPAM4 can be safety administered
- Trial name
- NCT00597129
- Testing
- 90Y-hPAM4
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Asthma
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of AZD9898
In this integrated, multi-part, Phase I study, the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD9898 will be investigated.
- Trial name
- NCT03140072
- Testing
- AZD9898
- Where
- 2 sites in United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
The purpose of this study is to evaluate and compare the dose proportionality of 324 mg Quinine Sulfate capsules following a single oral dose (1 x 324 mg capsules versus 2 x 324 mg capsules) in healthy adult volunteers when…
- Trial name
- NCT00726895
- Testing
- Quinine Sulfate Capsules 324 mg
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fed State
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg x1 tablets) at fed state
- Trial name
- NCT05739877
- Testing
- DA-1229_01 2.5/500mg (Before), DA-1229_01 2.5/500mg (After)
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy Volunteer
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers.
- Trial name
- NCT01433575
- Testing
- RO4917838
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Tumors
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced…
- Trial name
- NCT00298675
- Testing
- BSI-201 (iniparib), irinotecan
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- Sanofi
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