Clinical trials: Oral Cavity
Healthy
Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers
To establish bioequivalence at steady state of: 1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d.
- Trial name
- NCT01214109
- Testing
- pramipexole extended release, pramipexole immediate release
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Congestive Heart Failure
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin…
- Trial name
- NCT03962101
- Testing
- OPC-61815 injection
- Where
- Japan
- Volunteers
- 45 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- VICTORIA (NCT02861534)
- Testing
- Vericiguat
- Volunteers
- 5,050 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension…
- Trial name
- NCT00829764
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Healthy
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers
- Trial name
- NCT01681277
- Testing
- BI 113608 PIB bid, BI 113608 PIB qd
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Poliovirus Vaccine, Oral, COVID
OPV as Potential Protection Against COVID-19
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio.
- Conditions
- Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity
- Trial name
- NCT04445428
- Testing
- oral polio vaccine + information, Information
- Where
- Guinea-Bissau
- Volunteers
- 3,729 people
- Sponsor
- Bandim Health Project
Coronary Artery Disease
AZD5718 Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 in Patients With Coronary Artery Disease (CAD).
This is a randomized, single-blind, placebo-controlled, parallel-group, multicentre study in patients with CAD. The study will be conducted at approximately 10 centres in 3 countries.
- Trial name
- FLAVOUR (NCT03317002)
- Testing
- AZD5718
- Where
- 9 sites in Denmark, Finland and 1 more
- Volunteers
- 129 people
- Sponsor
- AstraZeneca
Thromboembolism
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR)…
- Trial name
- RE-COVER I (NCT00291330)
- Testing
- dabigatran etexilate 150 mg, warfarin (INR 2-3)
- Where
- 250 sites in United States, Argentina and 27 more
- Volunteers
- 2,564 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40.
- Trial name
- NCT00536107
- Testing
- Gefitinib, CT or MRI, Docetaxel
- Where
- Taiwan
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Hereditary Angioedema
A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
- Trial name
- NCT04208412
- Testing
- KVD900
- Where
- 25 sites in United States, Austria and 8 more
- Volunteers
- 84 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Healthy
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.
- Trial name
- NCT02431364
- Testing
- Verdinexor
- Where
- Australia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Karyopharm Therapeutics Inc
Myelofibrosis
Panobinostat and Ruxolitinib In MyElofibrosis (PRIME Trial)
This is a single-center, single arm, dose finding study to assess safety and tolerability of the oral combination of Panobinostat and Ruxolitinib in patients with myelofibrosis (MF) in chronic and accelerated phase.
- Trial name
- PRIME (NCT01693601)
- Testing
- Panobinostat, Ruxolitinib
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- John Mascarenhas
Acute Intracranial Hemorrhage
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
- Trial name
- NCT03661528
- Testing
- andexanet alfa, Usual Care
- Where
- 142 sites in United States, Austria and 22 more
- Volunteers
- 530 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet
The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as intravenous microtracer (Reference, R).
- Trial name
- NCT03783000
- Testing
- BI 425809, [C-14]-BI 425809
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pulmonary Hypertension
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary…
- Trial name
- VISION (NCT00302211)
- Testing
- Inhaled Iloprost (5 μg), Sildenafil, Bosentan
- Volunteers
- 67 people
- Sponsor
- Actelion
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Pulmonary Fibrosis
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
- Trial name
- NCT01170065
- Testing
- BIBF 1120
- Where
- 57 sites in Argentina, Australia and 19 more
- Volunteers
- 198 people
- Sponsor
- Boehringer Ingelheim
Healthy
Drug Interaction Study of Digoxin and BI 10773
The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and…
- Trial name
- NCT01306175
- Testing
- Digoxin plus BI 10773, Digoxin
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cow's Milk Allergy
Baked Milk Oral Immunotherapy for Cow's Milk Allergy
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
- Trial name
- NCT03462030
- Testing
- Baked non-fat cow's milk powder
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Johns Hopkins University
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