Clinical trials: Normal Healthy Subjects
Pharmacokinetics of Vepoloxamer, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Vepoloxamer, Healthy Volunteers, Renal Impaired
- Trial name
- NCT02646358
- Testing
- Vepoloxamer
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mast Therapeutics, Inc.
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers
The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers.
- Trial name
- NCT01550458
- Testing
- mibefradil
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cavion, Inc.
Parkinson Disease
WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
- Trial name
- NCT04513340
- Testing
- WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS
- Where
- India
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
HPV Infections, Cervical Cancer
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
- Conditions
- HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer
- Trial name
- NCT05372016
- Testing
- Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58), Active Comparator: GARDASIL ®9
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
Type 2 Diabetes Mellitus (T2DM), Renal Insuficiency
The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency
The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.
- Trial name
- RI (NCT06883656)
- Testing
- SAL067
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Systemic Lupus Erythematosus
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in…
- Trial name
- NCT02306629
- Testing
- Epratuzumab sc, Epratuzumab iv
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Staphylococcal Skin Infections, Streptococcal Infections
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single…
- Trial name
- NCT01030731
- Testing
- Ceftobiprole
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Sever Aplastic Anaemia
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as…
- Trial name
- NCT05088642
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Atopic Dermatitis
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102
The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects.
- Trial name
- NCT01423656
- Testing
- LEO 29102
- Where
- United Kingdom
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
Rheumatoid Arthritis
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
- Trial name
- NCT06883695
- Testing
- SHR-3045 Injection
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix
Healthy
Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment
To assess the influence of different degrees of renal impairment on safety, tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in comparison to a normal…
- Trial name
- NCT02254070
- Testing
- BIBT 986 BS
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dermatitis, Atopic
A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function.
- Trial name
- NCT02411162
- Testing
- Combination therapy GSK2894512 Cream A + GSK2894512 Cream B, Combination therapy Vehicle Cream A + Vehicle Cream B
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Stiefel, a GSK Company
Healthy
PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous…
- Trial name
- CYC102 (NCT02130414)
- Testing
- Sandimmun® IV, CyCol® capsules
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sigmoid Pharma
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Dermatitis, Atopic
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
- Trial name
- NCT04220411
- Testing
- AR100DP1
- Where
- Taiwan
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Arjil Pharmaceuticals LLC
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