Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed Conditions

An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fed Condition.

Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 days.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Torrent's Olmesartan Medoxomil Tablets 40 mg; Drug: Daiichi Sankyo Inc's Benicar Tablets 40 mg

Detailed Description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males with age between 18-45 years (both inclusive)
• Weight equal to or more than 50.00 Kgs
• BMI 18.50 - 24.90 Kg/m2
• Healthy as determined by medical history, clinical and laboratory examination performed within 21 days prior to admission day for the first period of the study.
• Must have provided written informed consent for participation in the study in the subject's vernacular language
• In the opinion of the Principal Investigator/Designee, be able to comply with the study procedures and protocol restrictions.

Exclusion Criteria:

• Known hypersensitivity or idiosyncratic reaction to Olmesartan, its excipients or similar classes of drugs
• Any evidence of significant abnormalities upon physical or clinical examination
• Sitting blood pressure less than 100/70 mm Hg or more than 140/90 mm Hg and radical pulse rate less than 60 mm Hg or more than 100 mm Hg per minute at the time of screening.
• Laboratory values, which are significantly different from predefined reference ranges and judged clinically significant.
• Any clinically significant abnormality in ECG.
• Any clinically significant abnormality in Chest X-ray (PA view)
• Regular use of tobacco or nicotine in significant amount in any form (e.g. use of more than 10 cigarettes a day) or have difficulty in abstaining from [smoking] nicotine use for the duration of the study period.
• History of drug dependence or excessive alcohol intake [subjects who drink more than 2 units per day (30 ml of 40% alcohol) or more than 14 units per week] on a habitual basis, or inability to abstain from alcohol for the duration of study period.
• History or presence of serious gastrointestinal, liver, kidney, heart, lung, neurological or blood disease, diabetes or glaucoma.
• History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension etc.
• Presence of disease markers of HIV 1 OR 2, Hepatitis B or C Viruses and VDRL.
• Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opioids) in urine.
• Positive test for alcohol breath analyzer test.
• History and presence of any psychiatric illness.
• History and presence of any illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g. NSAIDs
• History of significant blood loss (≥ 350 mL) due to any reason, including blood donation within last 12 weeks prior to screening.
• Existence of any surgical or medical condition which in the judgment of Principal Investigator/ Designee might interfere with the absorption, distribution, metabolism or excretion of the study drug, or, is likely to compromise the safety of subject.
• Intake of any enzyme-modifying drugs such as cimetidine, theophylline, benzodiazepines, ranitidine, proton pump inhibitors, erythromycin, diuretics, ketoconazole, anti hypertensive drugs, dopamine agonists, etc within 30 days of study drug administration, or administration/ intake of any prescription or OTC drug including vitamins and natural supplements within 30 days of study drug administration. In such cases, enrolment of the subject in the study will be at the discretion of the Principal Investigator/designee.
• Intake of unusual diet (e.g. low sodium) for two weeks prior to screening and throughout the subject's participation the study. In such case, subject selection will be at the discretion of the Principal investigator/ designee.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Torrent's Olmesartan Medoxomil Tablets 40 mg	Drug: Torrent's Olmesartan Medoxomil Tablets 40 mg
Active Comparator: Reference; Daiichi Sankyo Inc's Benicar Tablets 40 mg	Drug: Daiichi Sankyo Inc's Benicar Tablets 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	pre-dose to 72 hours post dose
AUC	pre-dose to 72 hours post dose

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: OLME/10/027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No