Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition

Open Label,Balanced,Randomized,Two-treatment,Two-sequence,Two Period,Single-dose,Crossover Oral Bioequivalence Study of Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets of Dr.Reddy's and Advil®PM of Wyeth in Normal,Healthy,Adult,Human Subjects Under Fasting Conditions.

To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ibuprofen and Diphenhydramine Citrate

Detailed Description

Detailed Description : The study was conducted as an Open label, balanced, randomized, two-treatment, two-sequence, two period,single-dose, crossover oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil@PM, of Wyeth Consumer Healthcare, USA., in normal, healthy, adult, human subjects under fasting conditions. A total number of forty (40) subjects were enrolled in the study and all the subjects completed both the periods of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Hyderabad
    • Amirpet, Hyderabad, India, 500 038
      • GVK Biosciences Pvt. Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy human subjects aged between 18 and 45 years (including both).
• Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
• Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
• Subjects having normal 12 lead electrocardiogram (ECG)
• Subjects having normal chest X-Ray (P/A view).
• Subjects able to communicate effectively.
• Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
• Female subjects who are postmenopausal or surgically sterile.
• Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (IUD) or abstinence.

Exclusion Criteria:

• Subjects having contraindications or hypersensitivity to Ibuprofen Diphenhydramine citrate or related group of drugs.
• History or presence of any medical conditions or disease according to the opinion of the physician.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
• Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50 beats/minute or more than 100 beats/minute.
• Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.
• Donation of blood in the past 3 months before screening.
• Female subjects demonstrating a positive pregnancy screen.
• Female subjects who are currently breast-feeding.
• Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen and Diphenhydramine Citrate; Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets of Dr. Reddy's	Drug: Ibuprofen and Diphenhydramine Citrate; Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets; Other Names: Advil PM
Active Comparator: Advil; Advil PM 200 mg/38 mg Tablets of Wyeth	Drug: Ibuprofen and Diphenhydramine Citrate; Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets; Other Names: Advil PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence study of Dr. Reddys Laboratories Limited, Ibuprofen and Diphenhydramine Citrate Caplets under fasting condition	2 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: N. Netaji, MD, GVK Biosciences Pvt. Ltd

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2010
• Last Update Submitted That Met QC Criteria: January 20, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence,Ibuprofen Diphenhydramine Citrate,Crossover
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine; Ibuprofen
• Other Study ID Numbers: 149-07