Clinical trials: Clinical Pharmacology
General Anxiety Disorder
Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
To evaluate the superiority of cognitive behavioral therapy using the Aurora® digital medical device + conventional drug treatment, compared to conventional drug treatment alone, in reducing anxiety symptoms, as assessed by the…
- Trial name
- NCT07477990
- Testing
- App AURORA (Digital Therapy) + conventional treatment, Pharmacological conventional treatment
- Where
- Mexico
- Volunteers
- 162 people
- Sponsor
- Psicofarma, S.A. De C.V.
Healthy
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates
This study consisted of 2 parts: Part 1 and 2. The purpose of this study was to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in…
- Trial name
- NCT05064488
- Testing
- Evobrutinib (45mg), Digoxin (0.25mg), Metformin (10mg)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Pharmacology, Clinical
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting…
- Trial name
- Orca (NCT03929861)
- Testing
- Fluconazole (BAYT006267) 150 mg capsules, Fluconazole 150 mg capsules (DiflucanTM)
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Premenopause
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been…
- Trial name
- NCT00628121
- Testing
- Cetrorelix
- Where
- Japan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Nippon Kayaku Co., Ltd.
Prediabetic State, Dysglycemia
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk
This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day, on cardiometabolic health and gut microbiota profile in overweight-obese…
- Conditions
- Prediabetic State, Dysglycemia, Overweight and Obesity
- Trial name
- NCT05369585
- Testing
- TOTUM-63
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Valbiotis
Healthy
Clinical Pharmacology of FYU-981 (Final Formulation)
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted…
- Trial name
- NCT03350373
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Asthmatic
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is…
- Trial name
- NCT01738087
- Testing
- NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg, NEXThaler 200/6 mcg DPI
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fibromyalgia
CBD (Cannabidiol)/THC (Tetrahydrocannabinol) Solution as a Pharmacological Strategy for Patients With Fibromyalgia (FibroCann)
Fibromyalgia is considered a chronic pain syndrome, non-inflammatory, of unknown etiology, which manifests itself in the musculoskeletal system in up to 2.5% of the general population, predominantly in females, mainly between 35…
- Trial name
- NCT05283161
- Testing
- cannabidiol and tetrahydrocannabinol
- Volunteers
- 40 people
- Sponsor
- FG Brasil LTDA
Healthy
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid
The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.
- Trial name
- NCT01009216
- Testing
- ABT-384
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Abbott
Hepatic Impairment
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
- Trial name
- NCT02624557
- Testing
- Alpelisib
- Where
- 4 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
In Vitro Fertilization
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a…
- Trial name
- NCT00696800
- Testing
- Corifollitropin alfa, RecFSH / Follitropin beta (Days 1 to 7), RecFSH / Follitropin beta (Days 8 to hCG)
- Volunteers
- 1,509 people
- Sponsor
- Organon and Co
HTLV-1-Associated Myelopathy (HAM)
A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)
The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM).
- Trial name
- NCT05240612
- Testing
- MT-3921
- Where
- Japan
- Volunteers
- 15 people
- Sponsor
- Tanabe Pharma Corporation
Clinical Pharmacology
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease.
- Trial name
- NCT04366622
- Testing
- Riociguat (Adempas, BAY 63-2521)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants
The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants.
- Trial name
- NCT05213481
- Testing
- Tepotinib, Carbamazepine
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Clinical Pharmacology of FYU-981 (Elder Subjects)
The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.
- Trial name
- NCT02344875
- Testing
- FYU-981, (Oral single dosing)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Fuji Yakuhin Co., Ltd.
Ulcerative Colitis
Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response…
- Trial name
- NCT02426372
- Testing
- QBECO SSI
- Where
- 3 sites in Canada
- Volunteers
- 11 people
- Sponsor
- Qu Biologics Inc.
Coronary Artery Disease (CAD)
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD).
- Trial name
- PLASMA (NCT00455546)
- Testing
- A-002
- Where
- 36 sites in United States, Ukraine
- Volunteers
- 400 people
- Sponsor
- Anthera Pharmaceuticals
Rheumatoid Arthritis
Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)
This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.
- Trial name
- NCT00144560
- Testing
- MRA(Tocilizumab)
- Volunteers
- 31 people
- Sponsor
- Chugai Pharmaceutical
Hepatic Impairment, Healthy Participants
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
- Trial name
- NCT03962049
- Testing
- Linzagolix
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ObsEva SA
Healthy
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive [Ethinyl estradiol/Norethisterone (EE/NET)] in healthy female participants.
- Trial name
- NCT07215806
- Testing
- Evobruitnib, Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany