Overview

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

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Olmesartan
Olmesartan Medoxomil
Criteria
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.