To estimate the bioavailability (amount of drug which reaches the blood) of GRC 17536 following oral administration in normal healthy male adults.

A randomized, open label, cross over study to evaluate the relative bioavailability of GRC 17536 following a single oral administration of three different tablet formulations (45 mg/90 mg/500 mg) with that of two different strengths of granule formulation (90 mg/ 250 mg) in normal healthy male adults.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/12/005320

Enrollment

Registered

2014-12-23

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 17536: Single dose, oral administration Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Normal healthy male volunteers of>=18 to 2. Healthy as determined by medical history, physical examination, chest X-ray, 12-lead ECG and laboratory investigations 3. Able and willing to abstain from alcohol and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, power drinks) 4. Able and willing to abstain from smoking and the use of other tobacco products

Exclusion criteria

Exclusion criteria: 1. Have abnormal and clinically significant results on the physical examination, medical history, chest X-ray, 12-lead ECG and lab investigations; 2. Volunteers with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease 3. History of alcohol abuse (or drug addiction as seen on positive screen on drugs of abuse or positive alcohol breath test. 4. Positive screen on hepatitis-B surface antigen (HBsAg), antibodies to the Hepatitis C virus (anti-HCV) or antibodies to the human immunodeficiency virus (HIV) 1/2; or rapid plasma reagin or VDRL. 5. Subjects with known history of liver disease or any abnormal liver function tests at screening 6. Current diagnosis of active epilepsy or any active seizure disorder requiring therapy with antiepileptic drug(s); 7. Subjects who have received any investigational drug in any clinical trial within last 3 months, or who are on extended follow-up.

Design outcomes

Primary

Measure	Time frame
Systemic exposure of GRC 17536 - Cmax, AUC Timepoint: 22 days	—

Secondary

Measure	Time frame
Adverse EventsTimepoint: 22 days;Clinical Parameters (Vitals, Physical Examination)Timepoint: 22 days;Laboratory ParametersTimepoint: 22 days;T1/2Timepoint: 22 days;TmaxTimepoint: 22 days	—

Countries

India

Contacts

Public ContactSivakumar Vaidyanathan

Glenmark Pharmaceuticals Ltd.

monika.tandon@glenmarkpharma.com912267720000

Outcome results