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N: Normal saline (placebo)
Normal saline is an inert isotonic solution that serves as a physiological control or placebo with no active pharmacological mechanism.
Normal saline is an isotonic solution of sodium chloride that serves as a physiological vehicle for drug delivery or fluid replacement with no active pharmacological mechanism. Used for Placebo control in clinical trials, Vehicle for parenteral drug delivery.
At a glance
| Generic name | N: Normal saline (placebo) |
|---|---|
| Sponsor | B.P. Koirala Institute of Health Sciences |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Normal saline (0.9% sodium chloride in water) is a sterile solution that matches the osmolarity and electrolyte composition of human blood plasma. It is used as a vehicle for drug delivery, a flush solution, or as a placebo control in clinical trials. It has no intrinsic therapeutic mechanism beyond maintaining fluid balance and electrolyte homeostasis.
Approved indications
- Placebo control in clinical trials
- Vehicle for intravenous drug delivery
- Fluid and electrolyte replacement
Common side effects
- Hyperchloremic acidosis (with prolonged high-volume infusion)
- Fluid overload
- Local irritation at injection site
Key clinical trials
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (PHASE4)
- First-in-Human PfSPZ-LARC2 Vaccination/CHMI (PHASE1)
- Improving Preterm Kidney Outcomes With Caffeine (PHASE2)
- Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults (PHASE1)
- Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection (PHASE2)
- Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia (PHASE2)
- Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- N: Normal saline (placebo) CI brief — competitive landscape report
- N: Normal saline (placebo) updates RSS · CI watch RSS
- B.P. Koirala Institute of Health Sciences portfolio CI