A clinical trial to compare blood levels of aliskiren/ amlodipine/ hydrochlorothiazide taken as individual drug products and as one single combination product containing three drugs

An open-label, randomized, two treatment, cross over, single dose study to evaluate bioequivalence between fixed-dose combination of 300/5/25 mg aliskiren/amlodipine/hydrochlorothiazide (HCTZ) tablet and free combination of market formulations of the 300 mg aliskiren, 5 mg amlodipine and 25 mg (HCTZ) in healthy subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000535

Enrollment

109

Registered

2009-08-31

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: 300/5/25 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

Primary

Measure	Time frame
To Determine Whether Fixed-Dose Combination Of 300/5/25 Mg Aliskiren/Amlodipine/Hydrochlorothiazide Tablet Is Bioequivalent To The Free Combination Of The Market Formulations Of 300 Mg Aliskiren Tablet, 5 Mg Amlodipine Capsule And 25 Mg Hydrochlorothiazide Capsule In Healthy Subjects.Timepoint: Single Fixed Dose Combination Of SAH100 Administration Followed By PK Sample Collection Till Day 8 (Except On Day 6) Crossover To Single Dose Of Free Combination Aliskiren/Amlodipine/Hydrochlorothiazide) Followed By PK Sample Collection Till Day 8 (Except On Day 6)	—

Measure

Time frame

To Determine Whether Fixed-Dose Combination Of 300/5/25 Mg Aliskiren/Amlodipine/Hydrochlorothiazide Tablet Is Bioequivalent To The Free Combination Of The Market Formulations Of 300 Mg Aliskiren Tablet, 5 Mg Amlodipine Capsule And 25 Mg Hydrochlorothiazide Capsule In Healthy Subjects.Timepoint: Single Fixed Dose Combination Of SAH100 Administration Followed By PK Sample Collection Till Day 8 (Except On Day 6) Crossover To Single Dose Of Free Combination Aliskiren/Amlodipine/Hydrochlorothiazide) Followed By PK Sample Collection Till Day 8 (Except On Day 6)

—

Secondary

Measure	Time frame
To Assess The Safety And Tolerability Of A Single Oral Dose Of The Fixed Combination Of Aliskiren/ Amlodipine/ Hydrochlorothiazide 300/5/ 25 Mg Tablet UnderTimepoint: 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	—

Countries

India

Contacts

Public ContactDr. K V Sureshkumar

Novartis Healthcare Pvt Ltd

suresh_kumar.kamireddy@novartis.com04067672944

Outcome results