To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01478022
• Date of registration: 14/11/2011
• Prospective Registration: No
• Primary sponsor: Parent Project, Italy
• Public title: To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20 ISOFEN1
• Scientific title: Open, Randomized, 3 Period Cross-over Design, in Healthy Volunteers to Compare the Pharmacokinetics Profiles of 3 Treatments: ISO 20, IBU 200 and IBU Plus ISO Combinations (200 + 20) Administered Per os as Single Doses
• Date of first enrolment: October 2011
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01478022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Italy

Contacts

• Name: Emilio Clementi
• Affiliation: Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy free-living

- Males between the age of 18 and 27

- Normal ECG

- Body Mass Index of 19.0-29.0 (Kg/m2)

- Subject healthy in the opinion of the Investigator

- Signed informed consent after verbal and written information

Exclusion Criteria:

- Clinically significant underlying systemic illness that may preclude the subject's
ability to complete the trial

- Any Gastrointestinal conditions which, in the opinion of the Investigator, may
interfere with the absorption of the drug or render the subjects unable to take oral
medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea,
gastrointestinal surgery)

- History of the following cardiac diseases SBP <120 mmHG or DBP < 80 mmHg

- Platelet count < 100000/mm3

- History of recurrent headache

- History of ongoing or clinically relevant glaucoma

- History of alcohol, drug or medication abuse within the past 2 years

- Treatment with norepinephrine, acetylcholine and histamine

- History or presence of allergy or intolerance to the study drugs or their components
or drugs of their class, or a history of drug or other allergy that, in the opinion of
the physician responsible, contraindicates their participation

- Participation in another study phase 1 with any investigational product within 6
months of screening



Age minimum: 18 Years
Age maximum: 27 Years
Gender: All

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy (DMD)

Intervention(s)

Drug: Isosorbide Dinitrate

Other: Ibuprofen and Isosorbide Dinitrate combination

Drug: Ibuprofen

Primary Outcome(s)

Pharmacokinetic parameter: AUC 0-12 [Time Frame: At period I, II and III with 7 days intervals between periods]

Secondary Outcome(s)

T max [Time Frame: At period I, II and III with 7 days intervals beteween periods]

C max [Time Frame: At period I, II and III with 7 days intervals between periods]

Adverse Events [Time Frame: 9 days]

Vital signs [Time Frame: 9 days]

Secondary ID(s)

ISOFEN1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors