A study to find out the variation in the absorption of SPA100 (aliskiren/amlodipine 300/10 mg oral tablets) when given with and with out food

A single center, open-label, randomized, two-period, crossover, single-dose study to determine the effect of food on the bioavailability of fixed combination SPA100 (aliskiren/amlodipine 300/10 mg oral tablets) in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000762

Enrollment

Registered

2009-10-07

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: SPA100 (aliskiren/amlodipine 300/10 mg oral tablets) with food: aliskiren/amlodipine 300/10 mg oral tablets with food Control Intervention1: SPA100 (aliskiren/amlodipine 300/10 mg oral

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and post menopausal female subjects age 18 to 45 years ready for written informed consent

Exclusion criteria

Exclusion criteria: Heavy smokers, drug addicts and alcoholics

Design outcomes

Primary

Measure	Time frame
To compare the bioavailability of aliskiren and amlodipine from a fixed combination aliskiren/amlodipine 300/10 mg oral tablets under fed and fasted conditionsTimepoint:	—

Secondary

Measure	Time frame
To assess the safety and tolerability of a single oral dose of a fixed combination of aliskiren/amlodipine 300/10 mg oral tabletsTimepoint:	—

Countries

India

Contacts

Public ContactVinu Jose,

Novartis Healthcare Private Limited

vinu.jose@novartis.com+91-40-6767-2946

Outcome results