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

Healthy Subjects Clinical Trial

Official title:

An Open Label, Randomized, 2-Period, 2- Treatment, 2 -Sequence, Crossover, Single-Dose BE Study of Nebivolol 20 mg Tablet [Torrent, India]Versus Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects - Fasted.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517020
• Other study ID #: PK-10-150
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.

Description:

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 Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting Condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Torrent's Nebivolol Tablets

• Forest Pharmaceuticals Inc's Bystolic Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		pre-dose to 8 hours post-dose
Primary	AUC		pre-dose to 8 hours fasting post-dose