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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01053338
• Date of registration: 20/01/2010
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
• Scientific title: 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 Fed Conditions.
• Date of first enrolment: April 2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01053338
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: N. Netaji, MD
• Affiliation: GVK Biosciences Pvt. Ltd

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Ibuprofen and Diphenhydramine Citrate

Primary Outcome(s)

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

Secondary ID(s)

155-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors