BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions

NCT02962258 | Completed Phase 1

• 1 other identifier: PK-10-156
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  Pre-dose to 72 hours after post dose

• AUC

  Pre-dose to 72 hours after post dose

Study Arms (2)

Test

EXPERIMENTAL

Torrent's Olmesrtan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg

Drug: Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets

Reference

ACTIVE COMPARATOR

Tribenzor of Daichi Sankyo Inc., USA

Drug: Tribenzor of Daichi Sankyo Inc. USA

Interventions

Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets DRUG

oral, crossover

Test

Tribenzor of Daichi Sankyo Inc. USA DRUG

oral, crossover

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male
• Age: 18-45 years (inclusive both)
• Volunteer with BMI of 18-25 (inclusive both) kg/m2
• Healthy and willing to participate in the study.
• Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
• Preferably Non-smokers

You may not qualify if:

• The volunteers were excluded from the study based on the following criteria:
• Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• Clinically significant abnormal ECG or Chest X-ray.
• Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
• Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.
• Respiratory rate less than 14/minute or more than 18/minute
• History of allergy to the test drug or any drug chemically similar to the drug under investigation.
• History of alcohol or drug abuse
• Positive breath alcohol test
• Recent history of kidney or liver dysfunction.
• History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
• Volunteers suffering from any chronic illness such as arthritis, asthma etc.
• History of heart failure.
• HIV, HCV, HBsAg positive volunteers.
• Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

MeSH Terms

Interventions

Amlodipine; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share