Clinical trial in Healthy Volunteers to test Valsartan Pharmacokinetics

Phase 1

• Conditions: Hypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004323-23-Outside-EU/EEA
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-21
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 86

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
Are the trial subjects under 18? no
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 86
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the rate and extent of absorption of valsartan between the valsartan pediatric FMI formulation and a valsartan CSF extemporaneous suspension;Secondary Objective: To assess the safety and tolerability of valsartan pediatric FMI formulation and valsartan CSF extemporaneous suspension. ;Primary end point(s): PK Parameters AUC0-t, AUC0-8, Camx,tmax and t1/2;Timepoint(s) of evaluation of this end point: End of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety;Timepoint(s) of evaluation of this end point: End of treatment