Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition

NCT01722110 | Completed Phase 1 DMC

• 1 other identifier: Ipca/ARL-10/436
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, male and female human subjects.

Conditions

Fed

Outcome Measures

Primary Outcomes (1)

• Bioequivalence is based on Cmax and AUC parameters.

  Sampling Hours: Pre-dose and at 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs post dose.

  2 months

Study Arms (2)

Indomethacin Extended-Release Capsules USP 75 mg

EXPERIMENTAL

Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India

Drug: Indomethacin Extended-Release Capsules USP 75 mg

Indomethacin Extended Release Capsules USP 75 mg

ACTIVE COMPARATOR

Indomethacin Extended Release Capsules USP 75 mg of Epic Pharma, USA.

Drug: Indomethacin Extended Release Capsules USP 75 mg

Interventions

Indomethacin Extended-Release Capsules USP 75 mg DRUG

75 mg tablet once a day

Also known as: Test Product

Indomethacin Extended-Release Capsules USP 75 mg

Indomethacin Extended Release Capsules USP 75 mg DRUG

75 mg tablet once a day

Indomethacin Extended Release Capsules USP 75 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and non pregnant female human subjects, age in the range of 18 - 45 years.
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
• Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
• Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis and 12 lead ECG.
• Subject's willing to give written informed consent.
• Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
• No history of significant alcoholism.
• No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
• Non-smokers were included.

You may not qualify if:

• Known history of hypersensitivity to Indomethacin or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History of malignancy or other serious diseases.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
• Found positive in breath alcohol test.
• Found positive in urine test for drug abuse.
• History of problem in swallowing.
• Any contraindication to blood sampling.
• Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
• Lactating women (currently breast feeding).

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Accutest Research Lab (I) Pvt. Ltd.

Navi Mumbai, Maharashtra, 400 709, India

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Suhas Khandave, M.D.

  Accutest Research Lab (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

IN (1)