E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the rate and extent of absorption of valsartan between the valsartan pediatric FMI formulation and a valsartan CSF extemporaneous suspension |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of valsartan pediatric FMI formulation and valsartan CSF extemporaneous suspension. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy male and female subjects age 18-55 years Vital signs :Oral Body temperature 35.0 - 37.5°C, systolic blood pressure 90 - 140 mm Hg, diastolic blood pressure 60 - 90 mm Hg, pulse rate 45 - 90 bpm , BMI 18-30 kg/m2 |
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E.4 | Principal exclusion criteria |
1. Use of any prescription medications, herbal supplements, or Over the counter medications,
2. Participation in any clinical investigation within four (4) weeks prior to initial dosing
3. Donation or loss of 400mLor more of blood within 8 weeks prior to initial dosing
4. Significant illness within two (2) weeks prior to initial dosing, a past medical history of clinically significant ECG abnormalities, recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc), Recent or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), history of multiple and recurring allergies or allergy to valsartan or its class being used in this study
5. Any planned surgery or procedure within 3 months of screening
6. Pregnant or lactating females
7. Presence of clinically significant abnormal lab values during screening
8. Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which could jeopardize the subject in case of participation in the study.
9. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result , a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
10. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and at each baseline
11. Presence of contraindications to the study treatments |
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E.5 End points |
E.5.1 | Primary end point(s) |
PK Parameters AUC0-t, AUC0-∞, Camx,tmax and t1/2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |