Comparative BA BE study of GlycerylTrinitrate 0.5 mg Sublingual Tablets of Troikaa Pharmaceuticals Ltd India andGlyceryl Trinitrate 0.5 mg SubLingual Tablets of Actavis UK Ltd in healthy subjects under fasting conditio

Phase 2

• Registration Number: CTRI/2020/01/023021
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects weight within normal range according to normal values for

Body Mass Index (18.50 to 30.00 kg/m2 (both inclusive)) with minimum

of 50 kg weight

Subjects with normal health as determined by personal medical and

medication history, clinical examination and laboratory examinations

within the clinically acceptable normal range

Subject having normal 2D Echocardiogram at screening

Subjects having clinically acceptable 12-lead electrocardiogram (ECG)

Subjects having clinically acceptable chest X-Ray (PA view)

Subjects having negative urine screen for drugs of abuse including

amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and

morphine, Methamphetamine, Codeine, Heroin and Phencyclidine

Non smokers and non-alcoholic subjects

Subjects having negative alcohol breath test

Exclusion Criteria

Hypersensitivity to Glyceryl Trinitrate or related class of drugs or any of its

excipients or heparin

Any difficulty with sublingual drug administration.

History or presence of significant, oromucosal, cardiovascular, pulmonary,hepatic, renal, gastrointestinal, endocrine, immunological, dermatological,urogenital, neurological or psychiatric disease or disorder

Sitting blood pressure less than 110/70 mm Hg and pulse rate less than 50 or

more than 100 beats per minute at the time of screening

Presence of orthostatic hypotension

Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of period 01

History or presence of alcoholism or drug abuse

History or presence of asthma, urticaria or other significant allergic reactions

History or presence of significant gastric and/or duodenal ulceration

History or presence of significant thyroid disease, adrenal dysfunction,

organic intracranial lesion such as pituitary tumor

History or presence of cancer or basal or squamous cell carcinoma

Study & Design

• Study Type: BA/BE
• Study Design: Not specified