A study to compare the concentrations of valsartan in plasma when valsartan is taken as solution formulation and as tablet formulation.

An open-label, randomized, single dose, two period, crossover study to determine the bioavailability of valsartan oral solution formulation relative to the valsartan tablet formulation (DiovanÂ®) in healthy adult subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001094

Enrollment

Registered

2010-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Valsartan solution (containing 80mg of valsartan): Single dose Control Intervention1: Valsartan 80 mg Tablet: Single dose

Eligibility

Inclusion criteria

Inclusion criteria: Healthy males and postmenopausal or surgically sterilized women of 18 to 45 years of age who grant informed consent

Exclusion criteria

Exclusion criteria: Smokers, drug addicts, those having immunodeficiency diseases

Design outcomes

Primary

Measure	Time frame
To compare the bioavailability of valsartan between the valsartan oral solution formulation and valsartan tablet (DiovanÂ®) formulation.Timepoint: End of the trial	—

Secondary

Measure	Time frame
To assess the safety and tolerability of valsartan oral solution and tablet formulationsTimepoint: End of trial;To perform exploratory pharmacogenetic assessments to examine whether individual genetic variation in genes relating to drug metabolism and the drug target pathway confer differential response to valsartan.Timepoint: End of trial;To perform palatability assessment of the formulationsTimepoint: End of trial	—

Measure

Time frame

To assess the safety and tolerability of valsartan oral solution and tablet formulationsTimepoint: End of trial;To perform exploratory pharmacogenetic assessments to examine whether individual genetic variation in genes relating to drug metabolism and the drug target pathway confer differential response to valsartan.Timepoint: End of trial;To perform palatability assessment of the formulationsTimepoint: End of trial

—

Countries

India

Contacts

Public ContactShibadas Biswal

Novartis

shibadas.biswal@novartis.com04067674607

Outcome results