Clinical trials: Single Women
Hepatic Impairment, Renal Impairment
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
- Trial name
- NCT05112419
- Testing
- Zibotentan
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Endometriosis Related Pain, Overactive Bladder
A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)
Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04487431
- Testing
- BAY1817080, [14C]BAY1817080
- Where
- Netherlands
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Bayer
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
End Stage Renal Disease (ESRD)
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.
- Trial name
- NCT04086212
- Testing
- Icodextrin, xylitol and carnitine solution for peritoneal dialysis, EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
- Sponsor
- Iperboreal Pharma Srl
Solid Tumor, Colon Carcinoma
PET-imaging of Two Vartumabs in Patients With Solid Tumors
VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS).
- Conditions
- Solid Tumor, Colon Carcinoma, Rectal Carcinoma, Osteosarcoma
- Trial name
- VARTUTRACE (NCT06645808)
- Testing
- 89Zr-DFO-N-Suc-F8scFv, 89Zr-DFO-N-Suc-C9scFv, PET/CT scan
- Where
- Netherlands
- Volunteers
- 32 people
- Sponsor
- Var2 Pharmaceuticals
Renal Impairment
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function.
- Trial name
- NCT02942810
- Testing
- WCK 5222
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Osteoporosis
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post…
- Trial name
- NCT00489424
- Testing
- Acetaminophen, Fluvastatin
- Where
- United States
- Volunteers
- 793 people
- Sponsor
- Novartis Pharmaceuticals
Group B Streptococcus
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
- Trial name
- NCT01150123
- Testing
- Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus (GBS) vaccine- High dose
- Where
- Belgium
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Alzheimer's Disease
Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
- Trial name
- NCT01454115
- Testing
- BMS-708163 (Gamma-Secretase Inhibitor)
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Psoriasis
Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
- Trial name
- NCT01577550
- Testing
- BI 655066 (very high i.v. dose), BI 655066 (high s.c. dose), BI 655066 (low i.v. dose)
- Where
- 9 sites in United States, Germany and 1 more
- Volunteers
- 39 people
- Sponsor
- AbbVie
Menopause, Healthy
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA)…
- Trial name
- NCT01596010
- Testing
- 2 mg estradiol / 1 mg norethisterone acetate (NETA)
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation.
- Trial name
- NCT02438696
- Testing
- BI 1060469, iFF, Test, BI 1060469, TF1, Reference, BI 1060469, TF2, Test
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pharmacokinetics
A Pharmacokinetics Study of Intravenous Ascorbic Acid
This is a Phase 1, single-dose study to evaluate the pharmacokinetics of intravenous Ascorbic Acid.
- Trial name
- NCT02534753
- Testing
- Ascor L 500® (Ascorbic Acid Injection, USP)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- McGuff Pharmaceuticals, Inc.
Menopause Syndrome, Menopause
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.
- Conditions
- Menopause Syndrome, Menopause, Hot Flashes
- Trial name
- NCT06385795
- Testing
- NOE-115
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Noema Pharma AG
Healthy
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.
- Trial name
- NCT01161966
- Testing
- Zonisamide, Zonegran
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03612856
- Testing
- AB023- Dose 1, AB023-Dose 2
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Aronora, Inc.
Healthy
Cefadroxil 500 mg Capsules Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company)…
- Trial name
- NCT00834275
- Testing
- Cefadroxil 500 mg Capsules, DURICEF® capsules 500 mg
- Where
- 2 sites in United States, Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Contraception
Sayana Press UK Self-Injection Study
A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).
- Trial name
- NCT03034057
- Testing
- Sayana Press
- Where
- 28 sites in United Kingdom
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- Pfizer
Severe Postpartum Haemorrhage
Treatment of Women After Severe Postpartum Haemorrhage
The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
- Trial name
- PP-02 (NCT01895205)
- Testing
- Iron isomaltoside 1000, Red blood cell transfusion
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Pharmacosmos A/S
Locally Advanced or, Metastatic Breast Cancer
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer.
- Trial name
- NCT02447328
- Testing
- Fulvestrant
- Where
- 9 sites in South Korea
- Volunteers
- 83 people
- Sponsor
- AstraZeneca
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