Clinical trials: Normal Healthy
Bioequivalence, AUC, Cmax, Pharmacokinetics
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co.
- Trial name
- NCT03121820
- Testing
- Memantinol tablets, 20 mg, Akatinol Memantine® tablets, 20 mg
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Geropharm
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
Malignancies Multiple
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
- Trial name
- NCT03346837
- Testing
- BMS-986205, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
Rheumatoid Arthritis
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc.
- Trial name
- NCT03868072
- Testing
- XELJANZ 5Mg Tablet, Chong Kun Dang Tofacitinib Tablet
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers
A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.
- Trial name
- NCT00968487
- Testing
- Lyophilized Plasma, Fresh Frozen Plasma
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- HemCon Medical Technologies, Inc
Renal Impairment, Healthy Volunteer
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
- Trial name
- NCT03890770
- Testing
- BMS-986165
- Where
- 6 sites in United States, Czechia and 2 more
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Arthritis, Rheumatoid
First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response.
- Trial name
- NCT03426995
- Testing
- GSK3358699, GM-CSF, LPS
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Community Acquired Pneumonia, Staphylococcal Skin Infections
First Time in Man Trial for Friulimicin B
The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine.
- Trial name
- NCT00492271
- Testing
- Friulimicin B
- Where
- Switzerland
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- MerLion Pharmaceuticals GmbH
Diabetes Type 2
A Study to Evaluate the Safety and Effectiveness of DM199 in Healthy Subjects and Type 2 Diabetes Patients
DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time that this compound is being given to humans.
- Trial name
- NCT01845064
- Testing
- DM199
- Where
- Netherlands
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- DiaMedica Therapeutics Inc
Atopic Dermatitis, Psoriasis
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
- Trial name
- NCT05718921
- Testing
- YR001 Dose A on low body surface area, YR001 Dose A on middle body surface area, YR001 Dose A on high body surface area
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Psoriasis
Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab)
Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and…
- Trial name
- NCT04744363
- Testing
- Stelara PFS
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Psoriasis
A Study of AK111 in Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111 in healthy subjects following SC…
- Trial name
- NCT03622021
- Where
- New Zealand
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Akesobio Australia Pty Ltd
Healthy Volunteer
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with…
- Trial name
- NCT07416955
- Testing
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Normal Healthy Volunteer, Safety After Oral Intake
A Research Study to Evaluate BLX-7006 in Healthy Adults
This study will test an oral medicine called BLX-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection.
- Trial name
- NCT07140055
- Testing
- BLX-7006
- Where
- Australia
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Biolexis Therapeutics
Parkinson Disease
PK Study of WD-1603 in Healthy Subjects
An open label, balanced, randomised, four-treatment, four-period, four-sequence, single oral dose, crossover Pharmacokinetics study of WD-1603 carbidopa/levodopa extended-release tablets in normal, healthy, adult human subjects…
- Trial name
- NCT04591535
- Testing
- WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
- Where
- India
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited
Healthy
Drug-Drug Interaction Study: ASP2151 and Midazolam
CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the induction effect of ASP2151 on that enzyme to determine the extent of any possible drug interactions.
- Trial name
- NCT02403635
- Testing
- Midazolam, ASP2151
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Maruho Europe Limited
Psoriasis
A Food Effect Study to Assess Pharmacokinetics of Hemay005 in Healthy Volunteers
The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.
- Trial name
- NCT03577626
- Testing
- Hemay005
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Tianjin Hemay Bio-Tech Co., Ltd
Soft Tissue, Soft Tissue Defects
First-in-Human Safety Study for Fractomer™ Biomatrix
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers.
- Conditions
- Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
- Trial name
- NCT07151638
- Testing
- Implantation (injection) of a new biomatrix for soft tissue support.
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- inSoma Bio, Inc.
Psoriasis
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male…
- Trial name
- NCT04371185
- Testing
- BAT2206, Stelara(US-licensed), Stelara(EU-licensed)
- Where
- China
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Bio-Thera Solutions
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