A clinical trial to study the effect of food on the blood levels of aliskiren, amlodipine and hydrochlorothiazide when the combination drug product containing these three drugs is administered with food.

An open-label, randomized, two treatment, cross over, single dose study to determine the effect of food on the pharmacokinetics of a fixed dose combination of aliskiren (SPP100)/ amlodipine/ hydrochlorothiazide 300/10/25 mg tablet in healthy subjects under fasted and fed condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000534

Enrollment

Registered

2009-08-19

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: Aliskiren + Amlodipine+ Hydrochlorothiazide: 300/10/25 mg Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects ( women of non-child bearing potential)

Exclusion criteria

Exclusion criteria: Female subjects of child bearing potential. Significant past or current illness Abnormal lab values Surgical or medical conditions which alter the ADME of drug

Design outcomes

Secondary

Measure	Time frame
To assess the safety and tolerability of a single oral dose of the fixed combination of aliskiren/ amlodipine/ hydrochlorothiazide 300/10/ 25 mg tablet under fasted and fed condition.Timepoint: Number of AEs from first dosing to end of study evaluation and number of SAEs from date of ICF to 4weeks after last dose administration	—

Primary

Measure	Time frame
To determine the effect of food on the pharmacokinetics of aliskiren, amlodipine and hydrochlorothiazide following single oral dose of fixed dose combination of aliskiren/ amlodipine/ hydrochlorothiazide 300/10/25 mg tablet under fasted and fed condition.Timepoint: Single dose of SAH100 administration under fasting or fed condition followed by PK sample collection till day 8 (except on Day 6)	—

Countries

India

Contacts

Public ContactDr. K V Sureshkumar

Novartis Healthcare Pvt Ltd

suresh_kumar.kamireddy@novartis.com04067672944

Outcome results