Completed PHASE1 INTERVENTIONAL 4-arm NCT03951402

Effect of a Multiple-dose Oral Administration of CG5503 PR on the Electrical Activity of the Heart in 48 Healthy Men and Women

Investigation of the Effect on the QT/QTc Interval After Multiple Dose Oral Administration (100 and 200 mg Bid) of CG5503 PR in a Randomised, Double-blind, Double-dummy Placebo- and Moxifloxacin-controlled 4- Way Cross-over Phase I Study in 48 Healthy Male and Female Volunteers

Sponsor: Grünenthal GmbH

Conditions Pharmacokinetic Prolonged QTc Interval

Interventions 100 mg CG5503 (tapentadol hydrochloride) PR tablet 400 mg Moxifloxacin tablet (overencapsulated) Placebo matching CG5503 PR tablet Placebo matching moxifloxacin capsule

Updated 4 times since 2019 Last updated: May 15, 2019 Started: Mar 31, 2003 Primary completion: Aug 31, 2003 Completion: Aug 31, 2003

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Pharmacokinetic and Prolonged QTc Interval and is currently completed. Grünenthal GmbH leads this study, which shows 4 recorded versions since 2003 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2019 — Jan 2021 [monthly]

Completed PHASE1

First recorded

Mar 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Grünenthal GmbH

Data source: Grünenthal GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Neuss, Germany