Bioavailability investigation of two different oral formulations of tetrazepam

Arzneimittel-Forschung/Drug Research

Volumn 50, Issue 4, 2000, Pages 328-332

  Geister, Ursula ^a,d   Gaupp, Markus ^a   Arnold, Peter ^a   Schaarschmidt, Dieter ^b   Doser, Karlheinz ^c  

^a Pharmakin GmbH   (Germany)

^b PHAROS GmbH   (Germany)

^c ratiopharm GmbH   (Germany)

^d NONE   (Germany)

Author keywords

1,4 Benzodiazepines; CAS 10379 14 3; Tetrazepam; Tetrazepam ratiopharmm, bioavailability, bioequivalencem, healthy volunteers

Indexed keywords

TETRAZEPAM;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG COATING; DRUG FORMULATION; DRUG MARKETING; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NORMAL HUMAN;

EID: 0034003175     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1300210     Document Type: Article

References (8)

1. [1] Salle, J., Brunaud, M., Tetrazepam, a new myorelaxant, pp. 443-445, Excerpta Medica, Amsterdam (1969)
2. [2] Bun, H., Philip, F., Berger, Y. et al., Plasma Levels and Pharmacokinetics of Single and Multiple Dose of Tetrazepam in Healthy Volunteers. Arzneim.-Forsch./ Drug Res. 37 (I), 199 (1987)
3. [3] Baumgaertner, M. G., Cautreels, W., Langenbahn, H., Biotransformation and pharmacokinetics of tetrazepam in man. Arzneim.-Forsch./Drug Res. 34 (II), 724 (1984)
4. [4] Shah, V. P., Midha, K. K., Dighe, S., Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. J. Pharm. Sci. 81, 309 (1992)
5. [5] Diletti, E., Hauschke, D., Steinijans, V. W., Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 30 (Suppl. 1), 51 (1992)
6. [6] CPMP-Note for Guidance 3C615A, Investigation of Bioavailability and Bioequivalence. The European Agency for the Evaluation of Medicinal Products, London
7. [7] Gardner, S., Bioavailability and bioequivalence requirements. Procedures for establishing a bioequivalence requirement. Fed. Reg. 42, 1624 (1977)
8. [8] Schulz, H.-U., Steinijans, V. W., Striving for standards in bioequivalence assessment. A review. Int. J. Pharmacol. Ther. Toxicol. 29, 293 (1991)