NCT00989404 (NAI113625) is a Phase 1 clinical trial of Zanamivir in Influenza A Virus, H1N1 Subtype, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00989404?

NCT00989404 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00989404?

Interventions in NCT00989404: Zanamivir, Zanamivir, Zanamivir.

What condition does NCT00989404 study?

NCT00989404 studies Influenza A Virus, H1N1 Subtype.

Is NCT00989404 still recruiting?

NCT00989404 is currently completed. Last updated 14 June 2017.

Last reviewed 2017-06-14 · How we verify

NCT00989404: NAI113625

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days

Completed Phase 1 Last updated 14 June 2017

What this trial tests

Phase 1 trial testing Zanamivir in Influenza A Virus, H1N1 Subtype in 18 participants. Completed in 7 December 2009.

Timeline

12 October 2009

Primary endpoint
7 December 2009

7 December 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	other
Enrollment	18
Start date	12 October 2009
Primary completion	7 December 2009
Estimated completion	7 December 2009
Sites	1 location across United States

Drugs / interventions tested

Zanamivir (ZANAMIVIR) — full drug profile →
Zanamivir (ZANAMIVIR) — full drug profile →
Zanamivir (ZANAMIVIR) — full drug profile →

Conditions studied

Influenza A Virus, H1N1 Subtype — all drugs for Influenza A Virus, H1N1 Subtype →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Influenza A Virus, H1N1 Subtype. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Zanamivir

Trials testing the same drug.

NCT04597437 — Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE) · Phase 2 · recruiting
NCT05648448 — A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza · Phase 2 · recruiting
NCT04494412 — An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection · Phase 2 · recruiting
NCT04867707 — Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes · Phase 2 · completed
NCT02377401 — Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults · Phase 1 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00989404 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 14 June 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00989404.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing