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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.

A randomized, open label, three way crossover relative bioavailability study in healthy adult male and female subjects to evaluate the bioavailability of GRC 4039 (1 mg and 5 mg) following single oral administration of a tablet formulation under fasting and fed conditions compared with that of a capsule in fasting condition.

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000428
Enrollment
Unknown
Registered
2009-07-01
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: GRC 4039: GRC 4039: single dose Tablet or capsule : 1mg and 5mg Control Intervention1: NIL: There is no active or placebo control in this study. Each subject serves as a control for him

Sponsors

Glenmark Pharmaceuticals SA, Chemin de la Combeta 5, 2300 La Chaux-de-Fonds, Switzerland
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactVishwas D. Sangle

Glenmark Pharmaceuticals ltd

binays@glenmarkpharma.com+91 22 67720000

Outcome results

None listed

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