Clinical study to evaluate the Safety, Tolerability and Pharmacokinetics of Tapentadol Nasal Spray in Healthy Human Volunteers

A Mono centric, Double Blind, Randomized, Placebo controlled Sequential Phase-I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Nasal Spray of Tapentadol HCl (Torrent Pharmaceuticals Ltd., India) following Single and Multiple Ascending Doses in Healthy Human Volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/12/005245

Enrollment

Registered

2014-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tapentadol Nasal Spray: Route of Administration:Nasal. Single and multiple dose ascending study Control Intervention1: Placebo Nasal Spray: Route of Administration:Nasal

Eligibility

Inclusion criteria

Inclusion criteria: 1. Sex: male 2. Age: 18 - 45 years (inclusive both) 3. Volunteer with BMI of 18.5-30 kg/m2 (inclusive both) with minimum of 50 kg weight. 4. Volunteer willing to provide written informed consent. 5. Non-smokers or smoker who smokes less than 10 cigarettes per day. 5Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion criteria

Exclusion criteria: 1. Inability to communicate or co-operate. 2. Volunteers suffering from any chronic illness such as asthma etc. 3. History of pre-existing bleeding disorder. 4. Clinically relevant abnormalities in the results of the laboratory screening evaluation. 5. Clinically significant abnormal ECG or Chest X-ray. 6. HIV, HCV, HbsAg positive volunteers. 7. History of significant blood loss due to any reason, including blood donation in the past 3 months. 8. Participation in any study within past 3 months. 9. History of alcohol or drug abuse. 10. History of consumption of prescribed medication since last 14 days or OTC medication/ herbal remedies since last 7 days before beginning of the study. 11. Positive to Breath alcohol test. 12. Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test. 13. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg. 14. Persistent pulse rate more than 100/minute. 15. Oral temperature more than 98.9Â°F. 16. Respiratory rate more than 20/minute 17. History of any drug allergy. 18. History of kidney or liver dysfunction within last 6 months. 19. Volunteers suffering from any psychiatric (acute or chronic) disorder. 20. 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. 21. H/O current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray. 22. H/O use of any medication by nasal route within past 72 hours of the study. 23. H/O tobacco sniffing. 24. H/O any chronic nasal conditions i.e., atrophic rhinitis, nasal polyp etc which can interfere with the absorption of the drug.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of ascending single and multiple doses of Tapentadol HCl administered as a nasal spray in healthy volunteers.Timepoint: NA	—

Secondary

Measure	Time frame
To study the pharmacokinetics of Tapentadol HCl nasal spray in healthy volunteers.Timepoint: NA	—

Countries

India

Contacts

Public ContactDr Deepa Joshi

Torrent Pharmaceuticals Ltd

deepajoshi@torrentpharma.com

Outcome results