Clinical trials: Childbirth
Pharmacokinetics
Effect of Delivery Route on PK of Sufentanil NanoTab
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.
- Trial name
- NCT01639729
- Testing
- Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Talphera, Inc
Migraine Headache
Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults
A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD) Device Nasal Spray) to that…
- Trial name
- NCT03401346
- Testing
- INP104, Dihydroergotamine Mesylate (DHE), Migranal Nasal Spray
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
Hypercholesteremia
Effects of Limicol on LDL-cholesterol
The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.
- Trial name
- NCT01354327
- Testing
- Limicol
- Where
- France
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Lescuyer Laboratory
Diphtheria, Hepatitis B
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity…
- Conditions
- Diphtheria, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00317161
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers, Medical Device
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut.
- Trial name
- NCT05314283
- Testing
- DV3395 C1
- Where
- Netherlands
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Seasonal Influenza
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule.
- Trial name
- ICC H1 (NCT01761123)
- Testing
- VXA-A1.1
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Vaxart
Smoking, Smoking Behaviors
Abuse Liability for Eight Electronic Nicotine Products
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine…
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Trial name
- NCT07323511
- Testing
- Product A, Product B, Product C
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Healthy
A Device Study in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given.
- Trial name
- NCT04848402
- Testing
- On-Body Delivery System (OBDS)/Multiple Bolus Injector, Single Auto Injector
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Infants
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to…
- Trial name
- NCT01896739
- Testing
- Eutravac
- Where
- 7 sites in South Korea
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Volunteers
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
- Trial name
- RaniPill (NCT03798912)
- Testing
- RaniPill capsule containing octreotide
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- RANI Therapeutics
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Innate Immunity
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group. The aim of the study was to investigate the immunity of infant born from caesarian section and fed with formula milk…
- Trial name
- NCT04256356
- Testing
- Feeding infants with formula milk with fermented matrix at dosage of 4.6 g per 100g of powder, Feeding infants with formula milk with fermented matrix at dosage of 6.9 g per 100g of powder, Feeding infants with standard formula milk
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Heinz Italia SpA
Healthy Volunteers
The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.
- Trial name
- NCT01535820
- Testing
- Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay, Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Infant Term Birth
Safety and Efficacy Study
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
- Trial name
- NCT02670863
- Testing
- Experimental Infant Formula, Standard Infant Formula
- Where
- Philippines
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
Users Study Of The Caverject Delivery System
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
- Trial name
- NCT01747928
- Testing
- dual-chamber syringe
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
Epstein-Barr Virus
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
- Trial name
- NCT07478952
- Testing
- mRNA-1189
- Where
- 2 sites in Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Contraception
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- ATI-CL13 (NCT01236768)
- Testing
- AG200-15, Levora
- Where
- 21 sites in United States
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Smoking Cessation
A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.
- Trial name
- NCT01234142
- Testing
- varenicline free base patch
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pfizer
Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS CoV-2
mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes
The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using…
- Trial name
- NCT06919796
- Testing
- COMIRNATY®
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- PharmaJet, Inc.