Clinical trials: Oral Complication
- Condition Oral Complication
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Renal Impairment
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and…
- Trial name
- NCT03235076
- Testing
- BAY1101042
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Diabetic Retinopathy, Diabetic Macular Edema
Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, NPDR - Non Proliferative Diabetic Retinopathy, PDR - Proliferative Diabetic Retinopathy
- Trial name
- ZETA-1 (NCT04692688)
- Testing
- APX3330
- Where
- 24 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc
Renal Impairment
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
- Trial name
- NCT01372826
- Testing
- NKTR118 Group1, NKTR118 Group 2, NKTR118 Group3
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Endometriosis, Uterine Fibroids
A Trial of SHR7280 in Healthy Subjects
The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
- Conditions
- Endometriosis, Uterine Fibroids, Assisted Reproduction
- Trial name
- NCT06969664
- Testing
- SHR7280 Tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Kidney Problems
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems.
- Trial name
- NCT05992155
- Testing
- TAK-279
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Endometriosis
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants.
- Trial name
- NCT04027192
- Testing
- BAY2328065 LSF, BAY2328065 tablet, Midazolam
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Kidney Disease, Healthy Volunteers
A Study to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body, How it Moves Into, Through and Out of the Body When Single and Multiple Amounts Are Taken as Tablets in Japanese Healthy Male Participants
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine.
- Trial name
- NCT05800444
- Testing
- BAY3283142
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Prostate Cancer, Endometriosis
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
- Trial name
- NCT02093390
- Testing
- TAK-385, Fluconazole, Atorvastatin
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Postoperative Complications, Constipation
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of…
- Trial name
- NCT00311350
- Testing
- MOA-728
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Endometriosis
A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets…
- Trial name
- NCT02807363
- Testing
- Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID, Leuprolide Depot
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Enteris BioPharma Inc.
Healthy
A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects.
- Trial name
- NCT01140672
- Testing
- PF-04634817
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetic Foot
BE STUDY OF METFORMIN GSK 1000mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 199/11 (NCT01710553)
- Testing
- Glucophage 1000mg, Metformin GSK 1000mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Severe Renal Impairment
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B): The 2 groups will be comparable in terms of age, gender, and body mass index (BMI)…
- Trial name
- NCT01043094
- Testing
- Pitavastatin 4mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Renal Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe…
- Trial name
- NCT06397872
- Testing
- 100 mg Resmetirom Tablet
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Healthy Volunteers, Patients
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
- Conditions
- Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment
- Trial name
- NCT01240967
- Testing
- TC-5214
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Impairment
Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function
Evaluation of the pharmacokinetics (PK) of TBPM-PI-HBr in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD)…
- Trial name
- NCT04178577
- Testing
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics