Bioequivalence Study of Torrent Pharmaceuticals 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] Vs Bystolic® 20 mg Tablet [ Forest Pharmaceuticals Inc., USA] in Healthy Subjects Fed Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517033
• Other study ID #: PK-12-151
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2018
• 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 Pharmaceuticals Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Ltd., USA) in Healthy Volunteers Under Fed Condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• 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 72 hours post-dose
Primary	AUC		pre-dose to 72 hours post-dose