Comparative BA BE study of Glyceryl Trinitrate 0.5 mg Sublingual Tablets of Troikaa Pharmaceuticals Ltd India and Glyceryl Trinitrate 0.5 mg SubLingual Tablets of Actavis UK Ltd in healthy subjects under fasting condition

An Open label balanced randomized single dose two treatment two sequence two period crossover comparative bioavailability bioequivalence study of Glyceryl Trinitrate 0.5 mg sublingual tableets of Troikaa Pharmaceuticals Ltd india and Glyceryl Trinitrate 0.5 mg sublingual tablet of Actavis UK ltd UK in healthy adult human subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023021

Enrollment

Registered

2020-01-28

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: Glyceryl Trinitrate: Glyceryl Trinitrate Sublingual Tablets 0.5 mg Dose 0.5 mg sublingual tablet frequency one sublingual tablet Control Intervention1: Actavis Tablets 0.5 mg: Glyceryl

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Cmax, AUC0-t and AUC0-infTimepoint: 1.00 min, 2.00 min, 3.00 min, 4.00 min, 5.00 min, 6.00 min, 7.00min, 8.00 min, 9.00 min, 10.00 min, 12.00 min, 15.00 min, 18.00 min, 20.00 min, 25.00 min, 30.00 min, 45.00 min, 1.00 hr, 1.25hr, 2.00 hr, 3.00 hr, and 4.00 hr	—

Secondary

Measure	Time frame
Tmax, AUC_%Extrap_obs, t1/2, and Î»Z.Timepoint: 1.00 min, 2.00 min, 3.00 min, 4.00 min, 5.00 min, 6.00 min, 7.00min, 8.00 min, 9.00 min, 10.00 min, 12.00 min, 15.00 min, 18.00 min, 20.00 min, 25.00 min, 30.00 min, 45.00 min, 1.00 hr, 1.25hr, 2.00 hr, 3.00 hr, and 4.00 hr	—

Countries

India

Contacts

Public ContactDr Darshan Kharadi

Veeda clinical research pvt ltd

darshan.kharadi@veedacr.com07930013000

Outcome results