Bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., in comparison with Nitromint® Retard Controlled Release tablet 2.6 mg (Nitroglycerin) of M/s Egis Pharma, Hungary in healthy, adult, human subjects under fasting condition.

Not yet recruiting

• Conditions: Fasting

• Registration Number: CTRI/2023/09/057205
• Lead Sponsor: Modi-Mundi Pharma Pvt. Ltd.

Brief Summary

**STUDY TITLE:**

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., in comparison with Nitromint® Retard Controlled Release tablet 2.6 mg (Nitroglycerin) of M/s Egis Pharma, Hungary in healthy, adult, human subjects under fasting condition.



**OBJECTIVES:**



**Primary objective:**

To compare the rate and extent of absorption of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., with that of Nitromint® Retard Controlled Release tablet 2.6 mg (Nitroglycerin) of M/s Egis Pharma, Hungary in healthy, adult, human subjects under fasting condition.



**Secondary objective:**

To monitor the safety and tolerability of the study subjects after administration of Nitroglycerin Controlled Release tablet 2.6 mg in healthy, adult, human subjects under fasting condition.

**Number of subjects**: Thirty two (32) subjects

**Duration of clinical study**: 09 days

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-09
• Study Start: 2023-11-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2 Willing to be available for the entire study period and to comply with protocol requirements 3 Normal healthy adult human subject of 18 45 years both inclusive of age 4 Body mass index in the range of 18 30 kg m2 both inclusive and weight at least 50kg 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician.

Exclusion Criteria

1 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs 2 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past 3 History of severe infection or major surgery in the past 6 months 4 History of Minor surgery or fracture within the past 3 months 5 Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal immunological or psychiatric diseases or organ dysfunction.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞	From Day 01 to Day 09

Secondary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2	From Day 01 to Day 09

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Rural, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Rural, KARNATAKA, India

Dr Priya R

Principal investigator

9900111997

pi.mail@icbiocro.com