Clinical trials: Single Dose
Recurrent Genital Herpes Simplex Type 2
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in…
- Trial name
- NCT06385327
- Testing
- ABI-5366
- Where
- 15 sites in Australia, New Zealand
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Clostridium Difficile Infection (CDI)
Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics
Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer…
- Trial name
- NCT07251127
- Testing
- Delayed-release metronidazole, Immediate-release metronidazole
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Gateway Pharmaceutical LLC
Healthy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug interactions between TMC435 and the combination of…
- Trial name
- NCT02064842
- Testing
- TMC647055, TMC435, Ritonavir (RTV)
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy Volunteers - Haemophilia A
A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).
- Trial name
- NCT05127473
- Testing
- Mim8 B, 10 mg/mL, Mim8 B, 100 mg/mL
- Where
- 2 sites in Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hypertension
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension
The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.
- Trial name
- NCT00933920
- Testing
- Aliskiren
- Where
- 5 sites in India
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Single and Multiple Ascending Doses of AZD1981 in Japan
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects
- Trial name
- JSAD/JMAD (NCT00698282)
- Testing
- AZD1981
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.
- Trial name
- NCT03808259
- Testing
- (S)-ketamine Oral Thin Film, (S)-ketamine IV Infusion
- Where
- Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Acute Myeloid Leukemia
Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients
The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.
- Trial name
- SPARK-AML1 (NCT00952588)
- Testing
- AZD1152, LDAC
- Where
- 45 sites in United States, Australia and 7 more
- Volunteers
- 74 people
- Sponsor
- AstraZeneca
Growth Hormone Deficiency
VRS-317 in Adult Subjects With Growth Hormone Deficiency
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients.
- Trial name
- NCT01359488
- Testing
- VRS-317
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Versartis Inc.
Epilepsy
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit.
- Trial name
- NCT02281526
- Testing
- BIA 2-093
- Where
- South Africa
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Infections, Bacterial
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG])…
- Trial name
- NCT02853435
- Testing
- Gepotidacin RC Tablet, Gepotidacin HSWG Tablet, Gepotidacin Capsule
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
The objectives of this study are: To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- Trial name
- hGH (NCT02146625)
- Testing
- CJ-40002
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Subjects With High LDL-Cholesterol
"A Clinical Study for Evaluating the Effect of a Plant Sterol-enriched Fermented Dairy Product on Blood Lipoprotein Profile in Japanese Adults"
INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH HIGH LDL-C.
- Trial name
- NCT02268318
- Testing
- 1-Fermented Dairy Product with Phytosterols (test), 2-Fermented dairy Product with No Phytosterols (control)
- Where
- Japan
- Volunteers
- 154 people
- Sponsor
- Danone Japan
Idiopathic Pulmonary Fibrosis, Lung; Disease, Interstitial, With Fibrosis
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers.
- Trial name
- NCT06482190
- Testing
- RSN0402 Part 1, RSN0402 Part 2
- Where
- 3 sites in Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shenzhen Resproly Biopharmaceutical Co., Ltd
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
COVID-19
Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness
This is a Phase 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate COVID-19 illness.
- Trial name
- NCT05298813
- Testing
- IBIO123
- Where
- 11 sites in Brazil, South Africa
- Volunteers
- 162 people
- Sponsor
- Immune Biosolutions Inc
Healthy
Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc.
- Trial name
- NCT00782548
- Testing
- KADIAN (morphine sulfate sustained-release) capsules, Avinza (morphine sulfate sustained-release) capsules
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Breast Cancer
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.
- Trial name
- NCT01367626
- Testing
- letrozole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Advanced Ovarian Cancer, Metastatic Breast Cancer
Bioequivalence Study of Liposomal Doxorubicin 20 mg/10 mL (Doxopeg® vs Caelyx®) in Advanced Cancer Patients
To characterize the pharmacokinetic profile of pegylated liposomal doxorubicin formulations, a multicenter, randomized, two-period crossover study was conducted in 74 patients with advanced ovarian cancer or metastatic breast…
- Trial name
- NCT07648940
- Testing
- Doxopeg® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL), Caelyx® - Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL)
- Where
- Brazil
- Volunteers
- 74 people
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
Magnetic Resonance Angiography, Peripheral Vascular Diseases
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg…
- Conditions
- Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases
- Trial name
- NCT00652418
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
- Where
- 3 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Bayer
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