Clinical trials: Physiologic Effects of Drugs
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Depressive Disorder, Treatment-Resistant, Stress Disorders, Post-Traumatic
Ketamine Infusions for PTSD and Treatment-Resistant Depression
The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning.
- Trial name
- NCT02577250
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Minneapolis Veterans Affairs Medical Center
Healthy, Elderly
The Effect of Caffeine in Elderly Citizen Following Eight Hour Abstinence From Caffeine Containing Drinks & Foods
The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods.
- Trial name
- NCT01048515
- Testing
- Caffeine
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Herning Hospital
Atropine Bioequivalence
Sublingual Atropine Bioequivalence by Route of Administration (SABER)
A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult…
- Trial name
- SABER (NCT06366087)
- Testing
- Atropine Sulfate Ophthalmic Solution USP, 1%, Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL)
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Virus Diseases, RNA Virus Infections
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT01991587
- Testing
- Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine, High dose of quadrivalent VLP vaccine
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medicago
Perinatal Depression, Post Partum Depression
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period.
- Conditions
- Perinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
- Trial name
- NCT04051320
- Testing
- Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet, Micronized progesterone
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Urinary Retention Postoperative, Laparoscopic Cholecystectomy
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital.
- Conditions
- Urinary Retention Postoperative, Laparoscopic Cholecystectomy, Neuromuscular Blockade, Sugammadex
- Trial name
- NCT05794503
- Testing
- Neostigmine, Sugammadex
- Where
- United States
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Type 1 Diabetes Mellitus
The Effect of Uric Acid Lowering in Type 1 Diabetes
Patients with type 1 diabetes mellitus (T1DM) are at high risk of developing kidney complications potentially leading to end stage renal disease.
- Trial name
- NCT02344602
- Testing
- Febuxostat
- Where
- Canada
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Anesthesia
EEG Study of IV Methylphenidate-Induced Emergence From Propofol Sedation
The investigators are performing this research study to find out if intravenous (IV) methylphenidate (commonly known as Ritalin) can help people recover faster from propofol sedation.
- Trial name
- NCT03610282
- Testing
- IV Methylphenidate, Propofol
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Basic Science
LSD Occupancy of the Serotonin 2A Receptor in the Human Brain
The investigators wish to quantify the relation between administered dose of lysergic acid diethylamide (LSD), plasma LSD levels, and occupancy at the serotonin 2A receptor (5-HT2AR) using [11C]CIMBI-36 positron emission…
- Trial name
- dOccLS (NCT05953038)
- Testing
- Lysergic Acid Diethylamide Tartrate
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Virus Diseases, RNA Virus Infections
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults
This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age.
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT03301051
- Testing
- Quadrivalent VLP Vaccine
- Where
- 73 sites in United States, Canada and 5 more
- Volunteers
- 10,160 people, healthy volunteers welcome
- Sponsor
- Medicago
Respiratory Tract Infections, Influenza
Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
- Trial name
- ViDiFlu (NCT01069874)
- Testing
- Cholecalciferol (Vitamin D/Vigantol oil), Miglyol oil
- Where
- 2 sites in United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Barts & The London NHS Trust
Healthy Volunteer
Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers
The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration…
- Trial name
- SNAP_MRI (NCT03440021)
- Testing
- ORM-12741
- Where
- South Africa
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Transgenderism, Clotting Disorder
Coagulation and Fibrinolysis of Estradiol in Transwomen
The specific aim for our study is to measure coagulation system activation and fibrinolysis following transdermal versus sublingual versus oral estradiol versus in transgender women.
- Trial name
- NCT05387577
- Testing
- Estradiol Tablets, Transdermal patch
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Exercise, Angiotensin-Converting Enzyme Inhibitors
Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity
The phenotype based on the insertion/deletion (I/D) polymorphism of the human angiotensin converting enzyme (ACE) gene has been associated with individual training response.
- Trial name
- NCT03949075
- Testing
- Enalapril
- Where
- Denmark
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Healthy
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
- Trial name
- NCT05763459
- Testing
- ABBV-CLS-7262
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Calico Life Sciences LLC
Preterm Birth, Obstetric Labor, Premature
Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial
Azithromycin is an antibiotic that is effective against bacteria that been associated with preterm birth (PTB). The purpose of this study is to evaluate if the addition of azithromycin prior to exam indicated cerclage prolongs…
- Conditions
- Preterm Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Trial name
- ALEC (NCT05132829)
- Testing
- Azithromycin 1 gram IV, Cefazolin and indomethacin
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Healthy
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the effects after single oral administration in…
- Trial name
- NCT02028598
- Testing
- Treatment 1, Treatment 2, Treatment 3
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- CTC Bio, Inc.
Alcohol Drinking, Binge Drinking
Alcohol, Behavior, and Brain Imaging
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.
- Conditions
- Alcohol Drinking, Binge Drinking, Drinking Behavior, Substance-Related Disorders
- Trial name
- (DARC) (NCT03930446)
- Testing
- Ethanol
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Major Depressive Disorder
Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®
The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in…
- Trial name
- NCT03357796
- Testing
- LY03005, Pristiq
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.