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To study the taste masking ability of cough formulation containing terbutaline sulphate and guaifenesin

Double-blind taste evaluation study (Gustatory Sensation Test) on terbutaline sulphate and guaifenesin cough formulations and comparison with Bricarex Syrup (produced by Astra zeneca Pharma India Ltd., India) in healthy, adult male human subjects under normal conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/08/006071
Enrollment
12
Registered
2015-08-03
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: NIL: Not applicable as this is a comparative study Control Intervention1: Bricarex syrup: Dose - Each 5 ml contains 1.5 mg terbutaline sulphate and 66.65 mg guaifenesin Frequency - twic

Sponsors

Sri Venkateshwara College of Pharmacy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) subjects aged between 18 to 45 both inclusive 2) Subject weight +/- 15% of ideal weight chart of LIC of India for non medical cases 3)Normal health as determined by personnel medical history and clinical examination 4) Subjects able to communicate effectively 5) Subjects willing to adhere to protocol requirements.

Exclusion criteria

Exclusion criteria: 1) hypersensitivity to terbutaline or guaifenesin or related drugs. 2) History or presence of allergic rhinitis, asthma, urticaria, anaphylaxis. 3) History or presence of significant smoking (more than 10 cigarettes or bidis/day) or consumption of tobacco products. 4) History or presence of significant alcoholism or drug abuses in the past one year 5) History or presence of significant gastric and duodenal ulceration. 6) History or presence of significant sour tongue and oral ulcers. 7) History or presence of cancer. 8) Use of any prescribed medication during last two weeks or OTC medical products during last one week preceding the first dosing. 9) Major illness during one month before screening 10) Subjects who have been on an abnormal diet for whatever reason during the four week during the screening 11) Participation in the drug research study within past 3 months. 12) Subjects who show sensitivity to the 1/10th concentration of standard quinine solution or super/non-taster by PROP method.

Design outcomes

Primary

MeasureTime frame
The film formulation tested could significantly mask the taste effectively when compared to reference syrup in all 12 subjects.Timepoint: 60 secs—

Secondary

MeasureTime frame
The formulated films were acceptable to the subjects in terms of palatability and disintegration time.Timepoint: 60 sec—

Countries

India

Contacts

Public ContactNalini Shastri

Sri Venkateshwara College of Pharmacy

svcphod@yahoo.co.in040-23118528

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026