A clinical trial to determine relative bioavailability of single oral administration of two different formulations (capsule vs. tablet) of GRC 4039 and to study the food effect when tablets are administered in fasted and fed state in healthy male and female volunteers.

Phase 1

Completed

• Registration Number: CTRI/2009/091/000428
• Lead Sponsor: Glenmark Pharmaceuticals SA, Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland

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: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Healthy males and females within the age range of 18 to 55 years
-Willingness to provide written informed consent to participate in the study
-Body-mass index of > 18.5 kg/m2 and < 24.9 kg/m2
-Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening

Exclusion Criteria

-Women of child bearing potential not willing to practice adequate contraception
-pregnant and lactating females
-Subjects with a relevant food or drug hypersensitivity or allergy
-Past history of anaphylaxis or angioedema
-Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
-Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test, renal (kidney) function test, etc.
-Subjects with a presence or a history of clinically relevant conditions in the gastrointestinal, hepatic, renal, urogenital, cardiovascular, metabolic, endocrine or central and peripheral nervous systems
-History of seizure or psychiatric disorders
-Use of any recreational drug or a history of drug addiction
-Participation in any clinical trial within the past 3 months
-Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
-Abnormal ECG

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Relative oral bioavailability of GRC 4039 (1mg and 5 mg) following single oral administration of GRC 4039 in a capsule formulation under fasting condition to that following tablet administration under fasting condition 2. Relative oral bioavailability of GRC 4039 (1mg and 5 mg) following single oral administration of GRC 4039 in a tablet formulation under fasting condition to that following tablet administration under fed conditionTimepoint: After crossover administration

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of GRC 4039 following single oral administration in a tablet formulation in fed and fasted state and following capsule administration in fasted state.Timepoint: After crossover administratation