Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet

Launched by TORRENT PHARMACEUTICALS LIMITED · May 4, 2018

Keywords

ClinConnect Summary

An Open Label, Randomized, 2- Period, 2 -Treatment, 2 -Sequence, Crossover, Single- dose Bioequivalence study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Ltd., USA) in Healthy Volunteers Under Fed Condition.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Sex: male
• • Age: 18-45 years (inclusive both)
• • Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
• • Healthy and willing to participate in the study.
• • Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
• • Non-smokers or smoker who smokes less than 10 cigarettes per day.
• Exclusion Criteria:
• • Inability to communicate or co-operate.
• • Volunteers suffering from any chronic illness such as arthritis, asthma etc.
• • History of pre-existing bleeding disorder.
• • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• • Clinically significant abnormal ECG or Chest X-ray.
• • HIV, HCV, HBsAg positive volunteers.
• • History of significant blood loss due to any reason, including blood donation in the past 3 months.
• • Participation in any study within past 3 months before entry to the study,
• • History of alcohol or drug abuse.
• • History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
• • Positive to breath alcohol test.
• • Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
• • Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• • Pulse rate less than 50/minute or more than 100/minute.
• • Oral temperature less than 95°F or more than 98.6°F.
• • Respiratory rate less than 12/minute or more than 20/minute.
• • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
• • Recent History of kidney or liver dysfunction.
• • Volunteers suffering from any psychiatric (acute or chronic) disorder.
• • Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.