Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01164787
• Date of registration: 16/07/2010
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions
• Scientific title: An Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Comparative Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited and Mavik® 4 mg Tablets of Abbott Laboratories, in Healthy, Adult, Human Subjects Under Fasting Conditions
• Date of first enrolment: March 2006
• Target sample size: 52
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01164787
• 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: Dr. Umesh Dhakate, M.B.B.S
• Affiliation: Wellquest Clinical Research

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy human subjects within the age range of 18 to 45 years

- Non-smokers since at least six months

- Willingness to provide written informed consent to participate in the study

- Body-mass index of = 18.5 kg/m2 and =24.9 kg/m2, with body weight not less than 50 kg

- Absence of significant disease or clinically significant abnormal laboratory values
on laboratory evaluations, medical history or physical examination during the
screening Normal 12-lead ECG or one with abnormality considered to be clinically
insignificant Normal chest X-ray PA view Comprehension of the nature and purpose of
the study and compliance with the requirement of the Protocol

- Female Subjects

- of child bearing potential 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, or

- postmenopausal for at least 1 year, or

- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the subject

Exclusion Criteria:

- Personal/family history of allergy or hypersensitivity to Trandolapril or allied
drugs

- 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 significCint abnormal values during screening e.g.
significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test
(RFT), etc.

- Any cardiac, renal or liver impairment, any other organ or system impairment

- History of seizure or psychiatric disorders

- Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus

- Consumption of alcohol for more than two years, or consumption of more than three
alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing
and during the study [one drink is equal to one unit of alcohol [one glass wine, half
pint beer, and one measure (one ounce) of spirit).

- Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate)
within 48 hours before check-in of each period

- Use of any recreational drug or a history of drug addiction

- Participation in any clinical trial within the past 3 months

- Inaccessibility of veins in left and right arm

- Donation of blood (one unit or 350 mL) within 3 months prior to receiVing the first
dose of study medication

- Regular smoker who has a habit of smoking more than nine cigarettes per day and has
difficulty in abstaining from smoking from 48 hours before dosing and until the
completion of the study.

- Receipt of any prescription drug therapy within four weeks or over-the-counter (OTC)
drugs within two weeks prior to receiving the first dose of study medication or
repeated use of drugs within the last four weeks

- An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to
receiving any medication and through out subject's participation in the study

- Consumption of grapefruit- containing food or beverages within 10 days prior to
receiving the first dose of study medication in both the periods

- Recent history of dehydration from diarrhoea, vomiting or any other reason within a
period of 24 hours prior to the study

- Female subjects who are pregnant or who are able (women with child bearing potential)
to become pregnant during the study will not be allowed to participate.



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

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Mavik

Drug: Trandolapril

Primary Outcome(s)

Bioequivalence is based on Cmax and AUC parameters. [Time Frame: 3 months]

Secondary ID(s)

CL-028-TRAN-2006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors