Clinical trials: Healthy Male/Female Subjects
Antimicrobial Agent, Cephalosporins
Effect of Ceftobiprole on Human Intestinal Microflora
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
- Conditions
- Antimicrobial Agent, Cephalosporins, Drug Resistance
- Trial name
- NCT00965042
- Testing
- Ceftobiprole
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
- Trial name
- NCT00659074
- Testing
- Ondansetron, Zofran
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Heart Failure
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function
A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.
- Trial name
- NCT03318809
- Testing
- AMG 986
- Where
- 4 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amgen
Pharmacology, Clinical
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose of 10 mg Immediate Release Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure).
- Trial name
- NCT04320771
- Testing
- Neladenoson bialanate (BAY 1067197)
- Where
- 2 sites in Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers
The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the blood and cerebrospinal fluid of healthy adult volunteers following administration of a single dose of JNJ-39393406.
- Trial name
- NCT01556217
- Testing
- JNJ-39393406
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Relative Bioavailability of a Linagliptin+Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects
Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet
- Trial name
- NCT02223026
- Testing
- Linagliptin/metformin FDC, high-fat, high caloric meal
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Dyslipidaemia
Study of the Electrocardiographic Effects of TA-8995
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.
- Trial name
- NCT02241759
- Testing
- TA-8995, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Xention Ltd
Healthy Volunteers
First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy male and female subjects.
- Trial name
- NCT02420782
- Testing
- ASP6282, Itraconazole, Pilocarpine
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy
A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmacokinetics of the new formulation following oral administration.
- Trial name
- NCT06624072
- Testing
- Nerandomilast 18 mg - adult formulation, Nerandomilast 1 mg - paediatric formulation
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Smoking Cessation
Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch
An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.
- Trial name
- NCT00965913
- Testing
- Nicotine Patch, Nicotine Patch Comparator
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- McNeil AB
Healthy
Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects
To demonstrate that BI 201335 does not prolong the QT interval more than placebo. To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before…
- Trial name
- NCT02182310
- Testing
- BI 201335 low dose, Moxifloxacin, BI 201335 high dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Osteoporosis
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout…
- Trial name
- NCT00846196
- Testing
- risedronate DR (Phase III clinical supply), risedronate 35 mg DR (Commercial Tablet)
- Where
- 6 sites in United States
- Volunteers
- 538 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
- Trial name
- NCT02251756
- Testing
- Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications, Actinica, 2 mg/cm2, 1 application
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Type 2 Diabetes, Diabetes Mellitus, Type 2
Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60 mg GFT505) and the old GFT505 formulation…
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases
- Trial name
- NCT01474161
- Testing
- GFT505 120mg - old formulation, GFT505 120mg - new formulation, GFT505 180mg - new formulation
- Where
- France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Genfit
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
Renal Failure
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
- Trial name
- NCT03241147
- Testing
- Lu AF35700
- Where
- Germany
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Renal Impairment
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.
- Trial name
- NCT01459250
- Testing
- AGO178C
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Subjects
Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain.
- Trial name
- NCT00536497
- Testing
- GW842166X
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Impairment, Renal Insufficiency
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers…
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Disease, Kidney Diseases
- Trial name
- NCT02039817
- Testing
- IDN-6556
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Conatus Pharmaceuticals Inc.