Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.

NCT02962336 | Completed Phase 1

• 1 other identifier: PK-10-155
• 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 Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide (40+10+25) mg Tablets

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

Reference

ACTIVE COMPARATOR

Tribenzor (40+10+25) mg Tablets of Daichi Sankyo Inc, USA

Drug: Tribenzor Tablets of Daichi Sankyo Inc, USA

Interventions

Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets DRUG

Oral, crossover

Test

Tribenzor Tablets 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
• 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; Tribenzor

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