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

NCT03319706 | Completed Phase 1

• 1 other identifier: OLME/10/027
• 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 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  pre-dose to 72 hours post dose

• AUC

  pre-dose to 72 hours post dose

Study Arms (2)

Test

EXPERIMENTAL

Torrent's Olmesartan Medoxomil Tablets 40 mg

Drug: Torrent's Olmesartan Medoxomil Tablets 40 mg

Reference

ACTIVE COMPARATOR

Daiichi Sankyo Inc's Benicar Tablets 40 mg

Drug: Daiichi Sankyo Inc's Benicar Tablets 40 mg

Interventions

Torrent's Olmesartan Medoxomil Tablets 40 mg DRUG

Test

Daiichi Sankyo Inc's Benicar Tablets 40 mg DRUG

Reference

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

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: October 19, 2017
• First Posted: October 24, 2017
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share