Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablet Under Fasting Conditions

NCT03318354 | Completed Phase 1

• 1 other identifier: OLME/10/026
• 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 Daichi 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 23, 2017
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 23, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share