FindTrial
Sign In

BIOAVAILABILITY AND BIOEQUIVALENCE OF TWO ORAL FORMULATION OF L-PROPIONYLCARNITINE TABLET VS SACHET IN HEALTHY VOLUNTEERS AT THE DOSE OF 2 G OPEN, RANDOMISED, TWO-WAYS CROSS-OVER, SINGLE DOSE STUDY

BIOAVAILABILITY AND BIOEQUIVALENCE OF TWO ORAL FORMULATION OF L-PROPIONYLCARNITINE TABLET VS SACHET IN HEALTHY VOLUNTEERS AT THE DOSE OF 2 G OPEN, RANDOMISED, TWO-WAYS CROSS-OVER, SINGLE DOSE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001114-14-IT
Enrollment
Unknown
Registered
2006-12-06
Start date
2004-10-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BIOEQUIVALENCE /BIOAVAILABILITY STUDY

Interventions

Trade Name: DROMOS*30CPR 500MG Product Name: L-Propionylcarnitine Pharmaceutical Form: INN or Proposed INN: Levocarnitine CAS Number: 119793-66-3 Current Sponsor code: ST 261 Concentration unit: m

Sponsors

SIGMA-TAU
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026