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

NCT03517020 | Completed Phase 1

• 1 other identifier: PK-10-150
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  pre-dose to 8 hours post-dose

• AUC

  pre-dose to 8 hours fasting post-dose

Study Arms (2)

Test

EXPERIMENTAL

Torrent's Nebivolol Tablets 20 mg

Drug: Torrent's Nebivolol Tablets

Reference

ACTIVE COMPARATOR

Forest Pharmaceuticals Inc.'s Bystolic® Tablets 20 mg

Drug: Forest Pharmaceuticals Inc's Bystolic Tablets

Interventions

Torrent's Nebivolol Tablets DRUG

Test

Forest Pharmaceuticals Inc's Bystolic Tablets DRUG

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: April 24, 2018
• First Posted: May 7, 2018
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 7, 2018

Record last verified: 2011-08