Cefdinir Capsules 300 mg, Fasting

• Sponsor: Teva Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00835484
• Collaborator: (none)
• Enrollment: 32
• Locations: 2
• Arms: 2
• Patients Per Site: 16

Study Details

Study Description

Brief Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg capsule) in healthy adult subjects administered under fasting conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Cefdinir Capsules 300 mg; Drug: OMNICEF® 300 mg	Phase 1

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Relative Bioavailability Study of 300 mg Cefdinir Capsules Under Fasting Conditions
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Cefdinir Capsules 300 mg; 1 x 300 mg, single-dose fasting
Active Comparator: 2	Drug: OMNICEF® 300 mg; 1 x 300 mg, single-dose fasting

Outcome Measures

Primary Outcome Measures

1. Cmax (Maximum Observed Concentration) [Blood samples collected over a 14 hour period.]

   Bioequivalence based on Cmax.

2. AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [Blood samples collected over a 14 hour period.]

   Bioequivalence based on AUC0-t.

3. AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [Blood samples collected over a 14 hour period.]

   Bioequivalence based on AUC0-inf.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. the subject's body mass index (BMI) should be 19 kg/m² - 30 kg/m², inclusive.

• Screening procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.

The screening clinical laboratory procedures will include:

• Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;

• Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;

• HIV antibody and hepatitis B surface antigen and hepatitis C antibody screens;

• Urinalysis: by dipstick; full microscopic examination if dipstick positive; and

• Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.

• Serum Pregnancy Screen (female subjects only)

If female and:

• of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD) or abstinence; or

• is postmenopausal for at least 1 year; or

• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

• Subjects with a recent history of drug or alcohol addiction or abuse.

• Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).

• Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.

• Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.

• Subjects demonstrating a positive drug abuse screen when screened for this study.

• Female subjects demonstrating a positive pregnancy screening.

• Female subjects who are currently breastfeeding.

• Subjects with a history of allergic response(s) to cefdinir or related drugs.

• Subjects with a history of clinically significant allergies including drug allergies.

• Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).

• Subjects who currently use or report using tobacco products within 3 months of Period I dose administration.

• Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.

• Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.

• Subjects who have donated serum (e.g. serumpheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate serum for four weeks after completing the study.

• Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.

• Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.

• Subjects who report an intolerance of direct venipuncture.

• Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.

• Subjects who report having difficulty fasting or consuming standardized meals.

• Female subjects who report using implanted or injected hormonal contraceptives (birth control) during the 6 months prior to Period I dosing.

• Female subjects who report using oral hormonal contraceptives (birth control) during the 14 days prior to Period I dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRACS Institute, Ltd.	East Grand Forks	Minnesota	United States	56721
2	PRACS Institute, Ltd.	Fargo	North Dakota	United States	58104

Sponsors and Collaborators

• Teva Pharmaceuticals USA

Investigators

• Principal Investigator: James D. Carlson, M.D., PRACS Institute, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00835484
• Other Study ID Numbers: R04-1122
• First Posted: Feb 3, 2009
• Last Update Posted: Aug 20, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Bioequivalence; Healthy Subjects
• Additional relevant MeSH terms: Cefdinir

Study Results

Participant Flow

Arm/Group Title	Cefdinir (Test) First	Omnicef® (Reference) First
Arm/Group Description	300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.	300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
Period Title: First Intervention
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cefdinir (Test) First	Omnicef® (Reference) First	Total
Arm/Group Description	300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.	300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 93.8%	16 100%	31 96.9%
>=65 years	1 6.3%	0 0%	1 3.1%
Sex: Female, Male (Count of Participants)
Female	8 50%	11 68.8%	19 59.4%
Male	8 50%	5 31.3%	13 40.6%
Race/Ethnicity, Customized (participants) [Number]
White	16 100%	16 100%	32 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	0 0%	1 3.1%
Not Hispanic or Latino	15 93.8%	16 100%	31 96.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	16 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Cmax (Maximum Observed Concentration)
Description	Bioequivalence based on Cmax.
Time Frame	Blood samples collected over a 14 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Cefdinir (Test)	Omnicef® (Reference)
Arm/Group Description	300 mg Cefdinir Capsules test product dosed in either period.	300 mg Omnicef® Capsules reference product dosed in either period.
Measure Participants	32	32
Mean (Standard Deviation) [ng/mL]	2995.84 (882.84)	3063.65 (823.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cefdinir (Test), Omnicef® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	97.15
	Confidence Interval	() 90%; 91.77 to 102.83
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

2. Primary Outcome

Title	AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Description	Bioequivalence based on AUC0-t.
Time Frame	Blood samples collected over a 14 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Cefdinir (Test)	Omnicef® (Reference)
Arm/Group Description	300 mg Cefdinir Capsules test product dosed in either period.	300 mg Omnicef® Capsules reference product dosed in either period.
Measure Participants	32	32
Mean (Standard Deviation) [ng*h/mL]	13953.75 (4108.87)	13795.54 (3892.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cefdinir (Test), Omnicef® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	100.8
	Confidence Interval	() 90%; 95.1 to 106.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

3. Primary Outcome

Title	AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Description	Bioequivalence based on AUC0-inf.
Time Frame	Blood samples collected over a 14 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Cefdinir (Test)	Omnicef® (Reference)
Arm/Group Description	300 mg Cefdinir Capsules test product dosed in either period.	300 mg Omnicef® Capsules reference product dosed in either period.
Measure Participants	32	32
Mean (Standard Deviation) [ng*h/mL]	14388.7 (4101.49)	14154.64 (3897.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cefdinir (Test), Omnicef® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	101.39
	Confidence Interval	() 90%; 95.89 to 107.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator is not permitted to discuss or publish trial results.