NCT01363999 is a Phase 1 clinical trial of atorvastatin in Healthy Volunteer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01363999?

NCT01363999 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01363999?

Interventions in NCT01363999: atorvastatin, dalcetrapib.

What condition does NCT01363999 study?

NCT01363999 studies Healthy Volunteer.

Is NCT01363999 still recruiting?

NCT01363999 is currently completed. Last updated 13 December 2019.

Are results published for NCT01363999?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-13 · How we verify

NCT01363999

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

A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers

Completed Phase 1 Results posted Last updated 13 December 2019

What this trial tests

Phase 1 trial testing atorvastatin in Healthy Volunteer in 24 participants. Completed in 1 July 2011.

Timeline

1 June 2011

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 June 2011
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	1 location across New Zealand

Drugs / interventions tested

atorvastatin (atorvastatin) — full drug profile →
dalcetrapib — full drug profile →

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plasma Concentration of Dalcetrapib Active Form
Time frame: 3 days
Plasma Concentration of Atorvastatin
Time frame: 3 days

Sponsor's own description

A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

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:

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Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

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NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
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Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT01363999 (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 Hoffmann-La Roche
Last refreshed: 13 December 2019

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/NCT01363999.

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