NCT03765801 is a Phase 1 clinical trial of GRTA9906 60 mg PR tablet in Pain, sponsored by Grünenthal GmbH.

Who is sponsoring NCT03765801?

NCT03765801 is sponsored by Grünenthal GmbH.

What drugs are being tested in NCT03765801?

Interventions in NCT03765801: GRTA9906 60 mg PR tablet, GRTA9906 60 mg IR capsule.

What condition does NCT03765801 study?

NCT03765801 studies Pain, Neuropathic Pain, Chronic Pain, Visceral Pain.

Is NCT03765801 still recruiting?

NCT03765801 is currently completed. Last updated 5 December 2018.

Last reviewed 2018-12-05 · How we verify

NCT03765801

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

A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it

Completed Phase 1 Last updated 5 December 2018

What this trial tests

Phase 1 trial testing GRTA9906 60 mg PR tablet in Pain in 22 participants. Completed in 11 December 2003.

Timeline

22 October 2003

Primary endpoint
11 December 2003

11 December 2003

Quick facts

Lead sponsor	Grünenthal GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	22 October 2003
Primary completion	11 December 2003
Estimated completion	11 December 2003
Sites	1 location across Germany

Drugs / interventions tested

GRTA9906 60 mg PR tablet — full drug profile →
GRTA9906 60 mg IR capsule — full drug profile →

Conditions studied

Pain — all drugs for Pain →
Neuropathic Pain — all drugs for Neuropathic Pain →
Chronic Pain — all drugs for Chronic Pain →
Visceral Pain — all drugs for Visceral Pain →

Sponsor

Grünenthal GmbH — full company profile →

Who can join

Adults 18 to 55, female only, with Pain or Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this clinical study in healthy women is to explore the intestinal uptake (bioavailability) of two different tablets of GRTA9906 (formulations) into the body and the effect of food on it. The intake of food may considerably influence the bioavailability, either by interaction with the compound itself or, if a prolonged release (PR) formulation is used, with the components of the tablet-matrix. For these reasons, the relative bioavailability and the effect of food on the bioavailability of GRTA9906 given as PR tablets compared to immediate release (IR) capsules will be assessed in this study. During the 4 periods of the study, each participant will receive two 60 mg GRTA9906 PR matrix tablets and two 60 mg GRTA9906 IR capsules under fed conditions (after consumption of a high-fat and high-calorie test meal) and fasting conditions (10 hours before dosing until 4.5 hours after dosing). In each period, the participant will receive the investigational product once.

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 Grünenthal GmbH trials

Trials by the same sponsor.

NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting
NCT07289776 — A First-in-human Trial of GRT7041 in Healthy Participants · Phase 1 · recruiting
NCT07317063 — A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants · Phase 1 · completed
NCT05449132 — Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the · Phase 3 · completed
NCT05377489 — Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis · Phase 3 · completed

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 NCT03765801 (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 Grünenthal GmbH
Last refreshed: 5 December 2018

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/NCT03765801.

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